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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 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.

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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).

Conditions Studied

Acute Ischemic Stroke Thrombotic Disease

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

FieldValue
Enrollment Target 106 participants
Start Date 2015-09
Est. Completion 2019-08-13
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

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What the Registry Record Tells You About NCT02586233

The ClinicalTrials.gov registry entry for NCT02586233 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 348-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (70% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.