Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke "ASSENT"

Recruiting

Phase 1/2 Results N/A

Update History

25 Oct '17
A location was updated in Houston.
New
The overall status was updated to "Recruiting" at Houston Methodist.
A location was updated in Pietra Ligure.
New
The overall status was updated to "Recruiting" at Ospedaliero di Albenga - Pietra Ligure Dept Neurology.
A location was updated in Taichung.
New
The overall status was updated to "Recruiting" at China Medical University Hospital.
30 Aug '17
A location was updated in Chicago.
New
The overall status was updated to "Recruiting" at Rush University Medical Center.
A location was updated in Columbia.
New
The overall status was updated to "Recruiting" at Palmetto Health, USC School of Medicine.
A location was updated in Ostrava Vitkovice.
New
The overall status was updated to "Recruiting" at Vitkovicka nemocnice a.s. Zaluzanskeho.
A location was updated in Ostrava.
New
The overall status was updated to "Recruiting" at Mestska nemocnice Ostrava.
A location was updated in Leipzig.
New
The overall status was updated to "Withdrawn" at Universitätsklinikum Leipzig.
A location was updated in Pisa.
New
The overall status was updated to "Recruiting" at Azienda Ospedaliero Universitaria.
A location was updated in Seongnam-si.
New
The overall status was updated to "Recruiting" at Seoul National University Bundang Hospital.
A location was updated in Seoul.
New
The overall status was updated to "Recruiting" at Samsung Medical Center.
4 Aug '17
The Summary of Purpose was updated.
New
This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded, Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in subjects with Acute Ischemic Stroke (AIS).
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This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded, Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in subjects with Acute Ischemic Stroke (AIS).
The eligibility criteria were updated.
New
Inclusion Criteria: - Men and women 18 years of age and older. - Subjects have a clinical diagnosis of acute ischemic stroke (including lacunar stroke) supported by computed topography or magnetic resonance imaging. - Subjects have stroke symptoms onset within 4.5 to 12 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptoms onset time refers to the last time the subject was known to be well. - Subjects have a NIHSS score of ≥ 2. - Subjects, (or their legally authorized representative-where applicable and based on country-specific practice), must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping. Exclusion Criteria: - Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. Eligible subjects declining these treatments can be enrolled to this study. - Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]). - Subjects have symptoms of subarachnoid hemorrhage, even with normal CT. - Subjects have an Alberta Stroke Program Early CT Score (ASPECTS) < 6. - Subjects have prior non-traumatic intracranial hemorrhage (excluding microhemorrahages observed in imaging). - Subjects have known arteriovenous malformation or aneurysm. - Subjects have evidence of active bleeding. - Subjects have platelet count < 100,000. - Subjects have International Normalized Ratio > 1.7. - Subjects have used unfractionated heparin within 24 hours prior to treatment and have an elevated partial thromboplastin time. - Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours prior to treatment. - Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment. - Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging. - Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit). - Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month. - Subjects have had major surgery within 14 days. - Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days. - Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days. - Subjects have a preexisting disability classified by mRS > 2. - Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2. - Subjects have baseline hemoglobin < 10.5 g/dL. - Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age). - Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug. - Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO ((INC Research), or the Site. - Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
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Inclusion Criteria: - Men and women 18 years of age and older. - Subjects have a clinical diagnosis of acute ischemic stroke (including lacunar stroke) supported by computed topography or magnetic resonance imaging. - Subjects have stroke symptoms onset within 4.5 to 12 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptoms onset time refers to the last time the subject was known to be well. - Subjects have a NIHSS score of ≥ 2. - Subjects, (or their legally authorized representative-where applicable and based on country-specific practice), must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping. Exclusion Criteria: - Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. Eligible subjects declining these treatments can be enrolled to this study. - Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]). - Subjects have symptoms of subarachnoid hemorrhage, even with normal CT. - Subjects have an Alberta Stroke Program Early CT Score (ASPECTS) < 6. - Subjects have prior non-traumatic intracranial hemorrhage (excluding microhemorrahages observed in imaging). - Subjects have known arteriovenous malformation or aneurysm. - Subjects have evidence of active bleeding. - Subjects have platelet count < 100,000. - Subjects have International Normalized Ratio > 1.7. - Subjects have used unfractionated heparin within 24 hours prior to treatment and have an elevated partial thromboplastin time. - Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours prior to treatment. - Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment. - Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging. - Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit). - Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month. - Subjects have had major surgery within 14 days. - Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days. - Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days. - Subjects have a preexisting disability classified by mRS > 2. - Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2. - Subjects have baseline hemoglobin < 10.5 g/dL. - Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age). - Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug. - Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO ((INC Research), or the Site. - Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
A location was updated in New York.
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The overall status was updated to "Withdrawn" at Icahn School Medicine at Mount Sinai.
3 Jun '17
The gender criteria for eligibility was updated to "All."
27 Aug '16
The eligibility criteria were updated.
New
Inclusion Criteria: - Men and women 18 years of age and older. - Subjects have a clinical diagnosis of acute ischemic stroke (including lacunar stroke) supported by computed topography or magnetic resonance imaging. - Subjects have stroke symptoms onset within 4.5 to 12 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptoms onset time refers to the last time the subject was known to be well. - Subjects have a NIHSS score of ≥ 2. - Subjects, (or their legally authorized representative-where applicable and based on country-specific practice), must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping. Exclusion Criteria: - Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. Eligible subjects declining these treatments can be enrolled to this study. - Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]). - Subjects have symptoms of subarachnoid hemorrhage, even with normal CT. - Subjects have an Alberta Stroke Program Early CT Score (ASPECTS) < 6. - Subjects have prior non-traumatic intracranial hemorrhage (excluding microhemorrahages observed in imaging). - Subjects have known arteriovenous malformation or aneurysm. - Subjects have evidence of active bleeding. - Subjects have platelet count < 100,000. - Subjects have International Normalized Ratio > 1.7. - Subjects have used unfractionated heparin within 24 hours prior to treatment and have an elevated partial thromboplastin time. - Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours prior to treatment. - Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment. - Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging. - Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit). - Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month. - Subjects have had major surgery within 14 days. - Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days. - Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days. - Subjects have a preexisting disability classified by mRS > 2. - Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2. - Subjects have baseline hemoglobin < 10.5 g/dL. - Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age). - Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug. - Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO ((INC Research), or the Site. - Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
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Inclusion Criteria: - Subjects have a clinical diagnosis of ischemic stroke in the anterior circulation (middle cerebral artery or anterior cerebral artery). - Men and women 18 to 80 years of age, inclusive. - Subjects have stroke symptom onset within 3 to 8 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptom onset time refers to the last time the subject was known to be well. - Subjects have a National Institute of Health Stroke Scale (NIHSS) score of 5 to 21, inclusive. - Subjects have a body weight of 50 kg to 120 kg, inclusive. - Subjects, or their legally authorized representative, must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping.. Exclusion Criteria: - Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]). - Subjects have symptoms of subarachnoid hemorrhage, even with normal CT. - Subjects have evidence of large middle cerebral artery (MCA) territory infarction (sulcal effacement or blurring of gray white junction in greater than 1/3 of MCA territory). - Subjects have assumed lacunar stroke based on the Principal Investigator's discretion according to symptom and imaging evidence. - Subjects have prior non-traumatic intracranial hemorrhage. - Subjects have known arteriovenous malformation or aneurysm. - Subjects have evidence of active bleeding. - Subjects have platelet count < 100,000. - Subjects have International Normalized Ratio > 1.7. - Subjects have used heparin within 48 hours prior to treatment or have an elevated partial thromboplastin time. - Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours prior to treatment. - Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 48 hours prior to treatment. - Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24 hours repeat brain imaging. - Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. - Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit). - Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 3 months. - Subjects have had major surgery within 14 days. - Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days. - Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days. - Subjects have a preexisting disability classified by mRS > 1. - Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2. - Subjects have baseline hemoglobin < 10.5 g/dL. - Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age). - Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half lives of that investigational drug prior to administration of the study drug. - Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO (PAREXEL), or the Site. - Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
25 Feb '16
The eligibility criteria were updated.
New
Inclusion Criteria: - Subjects have a clinical diagnosis of ischemic stroke in the anterior circulation (middle cerebral artery or anterior cerebral artery). - Men and women 18 to 80 years of age, inclusive. - Subjects have stroke symptom onset within 3 to 8 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptom onset time refers to the last time the subject was known to be well. - Subjects have a National Institute of Health Stroke Scale (NIHSS) score of 5 to 21, inclusive. - Subjects have a body weight of 50 kg to 120 kg, inclusive. - Subjects, or their legally authorized representative, must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping.. Exclusion Criteria: - Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]). - Subjects have symptoms of subarachnoid hemorrhage, even with normal CT. - Subjects have evidence of large middle cerebral artery (MCA) territory infarction (sulcal effacement or blurring of gray white junction in greater than 1/3 of MCA territory). - Subjects have assumed lacunar stroke based on the Principal Investigator's discretion according to symptom and imaging evidence. - Subjects have prior non-traumatic intracranial hemorrhage. - Subjects have known arteriovenous malformation or aneurysm. - Subjects have evidence of active bleeding. - Subjects have platelet count < 100,000. - Subjects have International Normalized Ratio > 1.7. - Subjects have used heparin within 48 hours prior to treatment or have an elevated partial thromboplastin time. - Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours prior to treatment. - Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 48 hours prior to treatment. - Subjects with anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24 hours repeat brain imaging. - Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. - Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit). - Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 3 months. - Subjects have had major surgery within 14 days. - Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days. - Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days. - Subjects have a preexisting disability classified by mRS > 1. - Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2. - Subjects have baseline hemoglobin < 10.5 g/dL. - Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age). - Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half lives of that investigational drug prior to administration of the study drug. - Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO (PAREXEL), or the Site. - Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
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Inclusion Criteria: - Subjects have a clinical diagnosis of ischemic stroke Middle Cerebral Artery (MCA) occlusion (M1 or M2), as demonstrated by Computed Tomography (CT) or Magnetic Resonance (MR) angiography. - Men and women 18 to 80 years of age, inclusive. - Subjects have stroke symptom onset within 3 to 8 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptom onset time refers to the last time the subject was known to be well. - Subjects have a NIH Stroke Scale (NIHSS) score > 4 and < 22. - Subjects have a body weight of 50 kg to 120 kg, inclusive. - Subjects, or their legally authorized representative, must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping. Exclusion Criteria: - Subjects have evidence of intracranial hemorrhage on noncontrast CT (or MR). - Subjects have symptoms of subarachnoid hemorrhage, even with normal CT. - Subjects have evidence of large MCA territory infarction (sulcal effacement or blurring of gray-white junction in greater than 1/3 of MCA territory). - Subjects have prior non-traumatic intracranial hemorrhage. - Subjects have known arteriovenous malformation or aneurysm. - Subjects have evidence of active bleeding. - Subjects have platelet count < 100,000. - Subjects have International Normalized Ratio INR > 1.7. - Subjects have used heparin within 48 hours or have an elevated partial thromboplastin time. - Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours. - Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 48 hours. - Subjects with anticipated use of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours of randomization. - Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke. - Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit). - Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 3 months. - Subjects have had major surgery within 14 days. - Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days. - Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days. - Subjects have a preexisting disability classified by modified Rankin Scale mRS > 1. - Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m*2. - Subjects have baseline hemoglobin < 10.5 g/dL. - Subjects have a positive pregnancy test. Serum pregnancy tests will be performed in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age). - Subject is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug. - Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO (PAREXEL), or the Site. - Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.