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Trial record 8 of 73 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.
Verified December 2017 by Daiichi Sankyo, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02586233
First Posted: October 26, 2015
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
  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: Triple (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586233


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

  Show 76 Study Locations
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
First Submitted: October 21, 2015
First Posted: October 26, 2015
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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