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Trial record 8 of 64 for:    assent

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Daiichi Sankyo Inc.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02586233
First received: October 21, 2015
Last updated: September 26, 2016
Last verified: September 2016
  Purpose
This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded, Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in subjects with Acute Ischemic Stroke (AIS).

Condition Intervention Phase
Acute Ischemic Stroke
Thrombotic Disease
Drug: DS-1040b
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Number and severity of adverse events [ Time Frame: from dose to 90 days post-dose ]
    To count the number and severity of treatment emergent adverse events (TEAEs) within 90 days post dose.


Secondary Outcome Measures:
  • Pharmacokinetic parameter, area under concentration curve (AUC) of DS-1040b in plasma [ Time Frame: 24 hours after dose ]
    Pharmacokinetic parameter AUC of DS-1040b in plasma

  • Pharmacokinetic parameter, tmax of DS-1040b in plasma [ Time Frame: 24 hours after dose ]
    Pharmacokinetic parameter tmax of DS-1040b in plasma

  • Pharmacokinetic parameter, maximum concentration Cmax of DS-1040b in plasma [ Time Frame: 24 hours after dose ]
    Pharmacokinetic parameter Cmax of DS-1040b in plasma

  • Pharmacokinetic parameter, amount of drug excreted in urine of DS-1040b in plasma [ Time Frame: 24 hours after dose ]
    Pharmacokinetic parameter amount of drug excreted in urine (Ae0-24) of DS-1040b in plasma

  • analysis for thrombin-activatable fibrinolysis inhibitor (TAFIa) antigen in plasma [ Time Frame: 24 hours after dose ]
    Pharmacodynamic analysis for thrombin-activatable fibrinolysis inhibitor (TAFIa) antigen in plasma

  • analysis for clot lysis in plasma [ Time Frame: 24 hours after dose ]
    Pharmacodynamic analysis for clot lysis (an exploratory biomarker) in plasma

  • analysis for D-dimer in plasma [ Time Frame: 24 hours after dose ]
    Pharmacodynamic analysis for D-dimer in plasma

  • analysis for total thrombin-activatable fibrinolysis inhibitor in plasma [ Time Frame: 24 hours after dose ]
    Pharmacodynamic analysis for total thrombin-activatable fibrinolysis inhibitor (total TAFIa) activity in plasma

  • Number of participants with AIS and a visible occlusion demonstrated on brain imaging at predose demonstrating recanalization at 24 hours. [ Time Frame: day 1 ]
  • Change by number and percentage in National Institute of Health Stroke Scale (NIHSS) score from predose to 30 days post-dose. [ Time Frame: day 0 (baseline) to day 30 ]
  • Change by number and percentage in modified Rankin Scale (mRS) score from baseline to day 90 [ Time Frame: day 0 (baseline) to day 90 ]

Estimated Enrollment: 96
Study Start Date: September 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DS-1040b
IV infusion of DS-1040b ranging from 0.6mg to 9.6mg of DS-1040b.
Drug: DS-1040b
IV infusion of DS-1040b
Placebo Comparator: placebo
placebo IV infusion
Drug: placebo
placebo IV infusion

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 years of age and older.
  • Subjects have a clinical diagnosis of acute ischemic stroke (including lacunar stroke) supported by computed topography or magnetic resonance imaging.
  • Subjects have stroke symptoms onset within 4.5 to 12 hours before initiation of study drug administration. For subjects with a wake-up stroke, symptoms onset time refers to the last time the subject was known to be well.
  • Subjects have a NIHSS score of ≥ 2.
  • Subjects, (or their legally authorized representative-where applicable and based on country-specific practice), must give written informed consent to participate in the study prior to participating in any study-related procedures. A separate written informed consent is required for collecting a blood sample for genotyping.

Exclusion Criteria:

- Subjects have been treated or are anticipated to be treated with tissue plasminogen activator and/or endovascular thrombectomy during current stroke.

Eligible subjects declining these treatments can be enrolled to this study.

  • Subjects have evidence of intracranial hemorrhage on non-contrast computed tomography (CT) (or magnetic resonance [MR]).
  • Subjects have symptoms of subarachnoid hemorrhage, even with normal CT.
  • Subjects have an Alberta Stroke Program Early CT Score (ASPECTS) < 6.
  • Subjects have prior non-traumatic intracranial hemorrhage (excluding microhemorrahages observed in imaging).
  • Subjects have known arteriovenous malformation or aneurysm.
  • Subjects have evidence of active bleeding.
  • Subjects have platelet count < 100,000.
  • Subjects have International Normalized Ratio > 1.7.
  • Subjects have used unfractionated heparin within 24 hours prior to treatment and have an elevated partial thromboplastin time.
  • Subjects have used a nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours prior to treatment.
  • Subjects have used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment.
  • Subjects with 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 of randomization. Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging.
  • Subjects have blood pressure > 185/110 mmHg, or require aggressive medication to maintain blood pressure below this limit (routine medical treatment is allowed to lower the blood pressure below this limit).
  • Subjects have had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month.
  • Subjects have had major surgery within 14 days.
  • Subjects have had gastrointestinal or genitourinary bleeding in the last 21 days.
  • Subjects have had a lumbar puncture (or epidural steroid injection) within 14 days.
  • Subjects have a preexisting disability classified by mRS > 2.
  • Subjects have an estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) < 60 mL/min/1.73 m2.
  • Subjects have baseline hemoglobin < 10.5 g/dL.
  • Subjects have a positive pregnancy test. Serum or urine pregnancy tests will be performed (according to site-specific practice) in women of childbearing potential (childbearing potential is assumed in women up to 55 years of age).
  • Subject 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.
  • Subject is an employee or an immediate family member of an employee of the Sponsor, the CRO ((INC Research), or the Site.
  • Any other reason, in the opinion of the Investigator, which precludes subject participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02586233

Contacts
Contact: INC Research DS1040-A-U103@incresearch.com

Locations
United States, Kentucky
Univ. of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Dr. Miller         
United States, New Jersey
JFK Neuroscience Inst. Recruiting
Edison, New Jersey, United States, 08820
Contact: Dr. Kirmani         
United States, New York
Icahn School Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
United States, North Carolina
Duke Univ. Medical Center Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State Univ. - Wexler Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Dr. Torbey         
United States, Oregon
Oregon Health and Science Univ. Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
United States, Tennessee
Chattanooga Center for Neurological Research Recruiting
Chattanooga, Tennessee, United States, 37403
France
Groupe Hospitalier Pellegrin Recruiting
Bordeaux, NAP, France, 33076
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand CEDEX, NAP, France, 63003
Germany
Klinikum Altenburger Land Recruiting
Altenburg, Germany, 04600
Univ. Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Univ. Leipzig Recruiting
Leipzig, Germany, 04103
Univ. Tubingen Recruiting
Tubingen, Germany, 72076
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Director: Jin Zhou, MD, PhD Daiichi Sankyo Inc.
  More Information

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02586233     History of Changes
Other Study ID Numbers: DS1040-A-U103
Study First Received: October 21, 2015
Last Updated: September 26, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Daiichi Sankyo Inc.:
Acute Ischemic Stroke in the anterior circulation

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 27, 2017