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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Acute Ischemic Stroke, Thrombotic Disease

In brief

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).

Key facts

Study ID: NCT02586233
Run by: Daiichi Sankyo
People needed: 106
Starts: 2015-09-01
Expected to finish: 2019-08-13
Last updated by the study team: 2020-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has a clinical diagnosis of acute ischemic stroke (including lacunar stroke/infarct) supported by computed topography or magnetic resonance imaging to rule out alternative cause for presenting symptoms
Has onset of stroke symptoms within 4.5 to 12 hours before initiation of study drug administration - for subjects with a stroke upon waking, time of symptom onset is the last time the subject was known to be well
Has a NIHSS score of ≥ 2 (for Cohorts 1-5) and ≥ 5 (for Cohort 6)
Has Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start completion and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging.
Is a Cohort 6 participant who is treated or anticipated to be treated with intra-arterial therapy (IAT) for ischemic stroke at the time of randomization (for enrollment in the IAT subgroup)
Has given written informed consent to participate in the study prior to participating in any study-related procedures - depending on country-specific practice, written informed consent may be acceptable from legally authorized representative
Has given a separate written informed consent for collecting a blood sample for genotyping

You may not qualify if…

Is a Cohort 1-5 participant who has been treated or is going to be treated with tissue plasminogen activator (tPA) and/or endovascular thrombectomy during current stroke
Is a Cohort 6 participant treated or anticipated to be treated with tPA during current stroke
Has evidence of intracranial hemorrhage on non-contrast computed tomography (CT/CAT) scan or magnetic resonance imaging (MRI)
Has symptoms of subarachnoid hemorrhage, even with normal imaging
Has an Alberta Stroke Program Early CT Score (ASPECTS) <6
Has prior non-traumatic intracranial hemorrhage (excluding microhemorrhages observed in imaging)
Has known arteriovenous malformation or aneurysm
Has evidence of active bleeding
Has platelet count less than 100,000
Has International Normalized Ratio greater than 1.7
Has used unfractionated heparin within 24 hours prior to treatment and has an elevated partial thromboplastin time
Has used a non-vitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours before treatment
Has used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment
Has 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 after completion of study drug treatment (low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment completion and after confirmation of no intracranial bleeding on the 24 hours repeat brain imaging. In Cohort 6, heparin treatment associated with IAT is allowed.)
Has blood pressure > 185/110 mmHg, or requires aggressive medication to maintain blood pressure below this limit (routine medical treatment including IV drug treatment is allowed to lower the blood pressure below this limit)
Has had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month
Has had major surgery within 14 days
Has had gastrointestinal or genitourinary bleeding in the last 21 days
Has had a lumbar puncture (or epidural steroid injection) within 14 days
Has had a preexisting disability classified by modified Rankin Scale (mRS) > 2
Has an estimated glomerular filtration rate < 60 mL/min/1.73 m\^2
Has baseline hemoglobin < 10.5 g/dL
Has a positive pregnancy test
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
Is an employee or an immediate family member of an employee of the Sponsor, the Contract Research Organization (CRO), or the Site

Where it is running

UCLA Medical Center Stroke Network — Los Angeles, California, United States
UC Health Memorial Hospital — Colorado Springs, Colorado, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
University of Louisville — Louisville, Kentucky, United States
Henry Ford Health System — Detroit, Michigan, United States
JFK Neuroscience Institute — Edison, New Jersey, United States
Icahn School Medicine at Mount Sinai — New York, New York, United States
Duke University Health System — Durham, North Carolina, United States
OSU - Wexner Medical Center — Columbus, Ohio, United States
Oregon Health Sciences University Hospital — Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Palmetto Health, USC School of Medicine — Columbia, South Carolina, United States
Chattanooga Center for Neurologic Research — Chattanooga, Tennessee, United States
Houston Methodist — Houston, Texas, United States
Royal North Shore Hospital — Sydney, New South Wales, Australia
Royal Adelaide Hospital Neurology Dept. — Adelaide, South Australia, Australia
Monash Health — Clayton, Victoria, Australia
Royal Melbourne Hospital — Parkville, Victoria, Australia
St. Annes University Hospital — Brno, Czechia
Vitkovicka nemocnice a.s. Zaluzanskeho — Ostrava Vitkovice, Czechia
CHRU Besançon - Hôpital Jean Minjoz — Besançon, France
Hôpital Pellegrin - CHU Bordeaux — Bordeaux, France
CHRU Lille - Hôpital Roger Salengro — Lille, France
University of South Alabama USA Health System — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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