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A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698513
Recruitment Status : Completed
First Posted : October 8, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 8, 2018
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE October 4, 2018
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to Day 33 ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to Day 95 ]
  • Incidence of Adverse Events (AEs) leading to discontinuation [ Time Frame: Up to Day 33 ]
  • Number of participants with vital sign abnormalities [ Time Frame: Up to Day 33 ]
  • Number of participants with 12-lead electrocardiogram (ECG) abnormalities [ Time Frame: Up to Day 33 ]
  • Number of participants with clinical laboratory abnormalities [ Time Frame: Up to Day 33 ]
  • Number of participants with physical examination abnormalities [ Time Frame: Up to Day 33 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03698513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Day 33 ]
    Cmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
  • Area under the plasma concentration time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to Day 33 ]
    AUC(TAU) of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
  • Time of maximum observed concentration (Tmax) [ Time Frame: Up to Day 33 ]
    Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
  • Terminal plasma half-life (T-HALF) [ Time Frame: Up to Day 33 ]
    T-Half of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
  • Trough observed plasma concentration (Ctrough) [ Time Frame: Up to Day 26 ]
    Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
  • Apparent total body clearance (CLT/F) [ Time Frame: Up to Day 33 ]
    CLT/F of BMS-986177, aspirin, clopidogrel
  • Volume of distribution (Vz/F) [ Time Frame: Up to Day 33 ]
    BMS-986177, aspirin, clopidogrel
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects
Official Title  ICMJE A Randomized, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986177 (an Oral Anti-thrombotic) With Single and Dual Antiplatelet Therapy (Aspirin and Clopidogrel) in Healthy Participants
Brief Summary This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: BMS-986177
    BMS-986177 capsule
  • Drug: Aspirin
    Aspirin tablet
  • Drug: Clopidogrel
    Clopidogrel tablet
  • Drug: Placebo (for BMS-986177)
    BMS-986177 placebo match capsule
Study Arms  ICMJE
  • Experimental: BMS-986177 + Aspirin + Clopidogrel
    BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 4-5)
    Interventions:
    • Drug: BMS-986177
    • Drug: Aspirin
    • Drug: Clopidogrel
  • Experimental: BMS-986177 (Part 1)
    BMS-986177 200 mg capsule twice daily (days 1-5)
    Intervention: Drug: BMS-986177
  • Placebo Comparator: BMS-986177 placebo + Aspirin + Clopidogrel
    BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)
    Interventions:
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Placebo (for BMS-986177)
  • Experimental: BMS-986177 (Part 2)
    BMS-986177 200 mg capsule twice daily (days 1-5)
    Intervention: Drug: BMS-986177
  • Placebo Comparator: BMS-986177 placebo + Clopidogrel
    BMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
    Interventions:
    • Drug: Clopidogrel
    • Drug: Placebo (for BMS-986177)
  • Experimental: BMS-986177 + Clopidogrel
    BMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
  • Experimental: BMS-986177 (Part 3)
    BMS-986177 200 mg capsule twice daily (days 1-5)
    Intervention: Drug: BMS-986177
  • Placebo Comparator: BMS-986177 placebo + Aspirin
    BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
    Interventions:
    • Drug: Aspirin
    • Drug: Placebo (for BMS-986177)
  • Experimental: BMS-986177 + Aspirin
    BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
    Interventions:
    • Drug: BMS-986177
    • Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2019)
113
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
108
Actual Study Completion Date  ICMJE February 19, 2019
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
  • Women not of childbearing potential (must have documented proof).
  • Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 for a total of 92 days after completion of study treatment. Male participants must additionally refrain from sperm donation during this time.

Exclusion Criteria:

  • Women of childbearing potential or who are breastfeeding.
  • Any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert.
  • History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration).
  • History of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm.
  • History of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months.
  • Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.
  • Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
  • History of any adverse reaction to anticoagulants or antiplatelet agents that resulted in excessive bleeding, requiring medication intervention.

Other protocol-defined inclusion/exclusion criteria could apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698513
Other Study ID Numbers  ICMJE CV010-034
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP