Safety and Tolerability of BIII 890 in Patients With Acute Ischemic Stroke

Completed

Phase 2 Results N/A

Trial Description

The objective of this study is to assess the safety, tolerability and pharmacokinetic characteristics of BIII 890 after intravenous infusion in acute ischemic stroke patients.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
  • BIII 890 CL Drug
    ARM 1: Kind: Experimental
    Label: BIII 890 CL
    Description: escalating doses

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of patients with adverse events up to 45 days No
Primary Number of patients with clinically relevant findings in vital signs up to 30 days No
Primary Number of patients with clinically relevant findings in electrocardiogram (ECG) up to 45 days No
Primary Number of patients with clinically relevant findings in laboratory evaluation up to 45 days No
Secondary Maximum concentration in plasma up to 120 hours after drug administration No
Secondary Time to reach maximum concentration in plasma up to 120 hours after drug administration No
Secondary Terminal elimination half-life up to 120 hours after drug administration No
Secondary Terminal rate constant up to 120 hours after drug administration No
Secondary Area under the plasma concentration-time curve up to 120 hours after drug administration No
Secondary Mean residence time up to 120 hours after drug administration No
Secondary Plasma clearance up to 120 hours after drug administration No
Secondary Volume of distribution at steady state up to 120 hours after drug administration No
Secondary Glutamate plasma concentrations up to 72 hours after start of infusion No
Secondary Change in modified Rankin Scale Baseline, day 30 No
Secondary Barthel Index Day 30 No
Secondary Change in NIH stroke scale Baseline, day 1, 3, 7 and 30 No

Sponsors