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NCT02586233 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
A Phase 1 study of Acute Ischemic Stroke and Thrombotic Disease, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
- 20
- Study locations
NCT02586233: Completed Phase 1 study of Acute Ischemic Stroke and Thrombotic Disease, sponsored by Daiichi Sankyo.
NCT02586233 is a Phase 1 study of Acute Ischemic Stroke and Thrombotic Disease that has completed, run by Daiichi Sankyo. The registered enrollment target is 106 participants, below the 348-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02586233, a Phase 1 study of Acute Ischemic Stroke and Thrombotic Disease, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).
Primary Outcome
Treatment-emergent adverse event (TEAE) is defined as an adverse event that emerges during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at predose; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment relative to the pre-dose state, when the adverse event is continuous.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DS-1040b
Study Locations (20)
Kentucky
- University of Kentucky Chandler Medical Center - Lexington
- University of Louisville - Louisville
Victoria
- Monash Health - Clayton
- Royal Melbourne Hospital - Parkville
Alabama
- University of South Alabama USA Health System - Mobile
California
- UCLA Medical Center Stroke Network - Los Angeles
Colorado
- UC Health Memorial Hospital - Colorado Springs
Illinois
- Rush University Medical Center - Chicago
Michigan
- Henry Ford Health System - Detroit
New Jersey
- JFK Neuroscience Institute - Edison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-08-13 |
| Phase | Phase 1 |
What the finished NCT02586233 record still lists
NCT02586233 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 348-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02586233 names 20 study sites across 18 states, led by Kentucky, Victoria, Alabama.
Frequently Asked Questions
What is clinical trial NCT02586233 about?
NCT02586233 is a clinical study titled "Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke". This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).
What is the current status of trial NCT02586233?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2015-09. Estimated completion is 2019-08-13.
What conditions does trial NCT02586233 study?
This clinical trial studies the following conditions: Acute Ischemic Stroke, Thrombotic Disease.
What interventions are being tested in trial NCT02586233?
The interventions under investigation include: Placebo (DRUG), DS-1040b (DRUG).
Who is sponsoring clinical trial NCT02586233?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02586233 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02586233's enrollment target sits among peer trials
106 19th of 25 higher than 7 of 25 other Acute Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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