DS1040b/Aspirin Drug/Drug Interaction Study

Completed

Phase 1 Results N/A

Trial Description

This is a phase 1, open label, single dose study, after 5 days of aspirin treatment, in healthy male and female subjects. It is hypothesized that co-administering DS-1040b with aspirin at steady state will be safe and well tolerated by healthy male and female subjects.

Conditions

Interventions

  • Aspirin Drug
    Intervention Desc: Dispersible tablet, 300mg & 75 mg, once daily for 5 days
    ARM 1: Kind: Experimental
    Label: Aspirin
    Description: Dispersible tablet, 300mg & 75 mg, once daily for 5 days
  • DS-1040b Drug
    Intervention Desc: IV of 6 mg given once over 30 minutes
    ARM 1: Kind: Experimental
    Label: DS-1040b
    Description: IV of 6 mg given once over 30 minutes

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Basic Science
  • Endpoint: Pharmacokinetics/Dynamics Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary bleeding time day 0 to day 5 after dosing Yes
Secondary change in D-dimer level day 0 - day 5 after dosing No
Secondary Cmax Days 5, 6, and 7 after dosing No
Secondary Tmax Days 5, 6, and 7 after dosing No
Secondary AUC Days 5, 6, and 7 after dosing No
Secondary half-life Days 5, 6, and 7 after dosing No

Sponsors