Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:
This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: BMS-986177 Drug: Aspirin Drug: Clopidogrel Drug: Placebo (for BMS-986177) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2018
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: BMS-986177
BMS-986177 capsule

Drug: Aspirin
Aspirin tablet

Drug: Clopidogrel
Clopidogrel tablet

Experimental: BMS-986177 (Part 1)
BMS-986177 200 mg capsule twice daily (days 1-5)
Drug: BMS-986177
BMS-986177 capsule

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)
Drug: Aspirin
Aspirin tablet

Drug: Clopidogrel
Clopidogrel tablet

Drug: Placebo (for BMS-986177)
BMS-986177 placebo match capsule

Experimental: BMS-986177 (Part 2)
BMS-986177 200 mg capsule twice daily (days 1-5)
Drug: BMS-986177
BMS-986177 capsule

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)
Drug: Clopidogrel
Clopidogrel tablet

Drug: Placebo (for BMS-986177)
BMS-986177 placebo match capsule

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)
Drug: BMS-986177
BMS-986177 capsule

Drug: Clopidogrel
Clopidogrel tablet

Experimental: BMS-986177 (Part 3)
BMS-986177 200 mg capsule twice daily (days 1-5)
Drug: BMS-986177
BMS-986177 capsule

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)
Drug: Aspirin
Aspirin tablet

Drug: Placebo (for BMS-986177)
BMS-986177 placebo match capsule

Experimental: BMS-986177 + Aspirin
BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
Drug: BMS-986177
BMS-986177 capsule

Drug: Aspirin
Aspirin tablet




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to Day 33 ]
  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to Day 95 ]
  3. Incidence of Adverse Events (AEs) leading to discontinuation [ Time Frame: Up to Day 33 ]
  4. Number of participants with vital sign abnormalities [ Time Frame: Up to Day 33 ]
  5. Number of participants with 12-lead electrocardiogram (ECG) abnormalities [ Time Frame: Up to Day 33 ]
  6. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to Day 33 ]
  7. Number of participants with physical examination abnormalities [ Time Frame: Up to Day 33 ]

Secondary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Day 33 ]
    Cmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  2. 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

  3. Time of maximum observed concentration (Tmax) [ Time Frame: Up to Day 33 ]
    Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  4. 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

  5. Trough observed plasma concentration (Ctrough) [ Time Frame: Up to Day 26 ]
    Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

  6. Apparent total body clearance (CLT/F) [ Time Frame: Up to Day 33 ]
    CLT/F of BMS-986177, aspirin, clopidogrel

  7. Volume of distribution (Vz/F) [ Time Frame: Up to Day 33 ]
    BMS-986177, aspirin, clopidogrel



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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): NCT03698513


Locations
Layout table for location information
United States, Texas
PPD Austin Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03698513     History of Changes
Other Study ID Numbers: CV010-034
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents