A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT03698513
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Inclusion Criteria
- Must have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Must have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of > 80 mL/min/1.73 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in the urine
For Parts 1 and 2:
• Must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline).
Exclusion Criteria
- 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.
Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BMS-986177 + Aspirin + Clopidogrel (Part 1) BMS-986177 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 2-5) BMS-986177 (Part 1) BMS-986177 BMS-986177 200 mg capsule twice daily (days 1-5) BMS-986177 placebo + Aspirin + Clopidogrel (Part 1) Placebo (for BMS-986177) 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) BMS-986177 placebo + Aspirin + Clopidogrel (Part 1) 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) BMS-986177 placebo + Aspirin + Clopidogrel (Part 1) Aspirin 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) BMS-986177 (Part 2) BMS-986177 BMS-986177 200 mg capsule twice daily (days 1-5) BMS-986177 placebo + Clopidogrel (Part 2) 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) BMS-986177 + Clopidogrel (Part 2) BMS-986177 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) BMS-986177 (Part 3) BMS-986177 BMS-986177 200 mg capsule twice daily (days 1-5) BMS-986177 placebo + Aspirin (Part 3) Placebo (for BMS-986177) BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) BMS-986177 + Aspirin (Part 3) BMS-986177 BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) BMS-986177 placebo + Clopidogrel (Part 2) Placebo (for BMS-986177) 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) BMS-986177 + Aspirin + Clopidogrel (Part 1) 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 2-5) BMS-986177 + Aspirin + Clopidogrel (Part 1) Aspirin 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 2-5) BMS-986177 + Clopidogrel (Part 2) 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) BMS-986177 placebo + Aspirin (Part 3) Aspirin BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) BMS-986177 + Aspirin (Part 3) Aspirin BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to Day 33 Incidence of Serious Adverse Events (SAEs) Up to Day 95 Number of participants with 12-lead electrocardiogram (ECG) abnormalities Up to Day 33 Incidence of Adverse Events (AEs) leading to discontinuation Up to Day 33 Number of participants with vital sign abnormalities Up to Day 33 Number of participants with physical examination abnormalities Up to Day 33 Number of participants with clinical laboratory abnormalities Up to Day 33
- Secondary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) 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)] Up to Day 33 AUC(TAU) of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
Time of maximum observed concentration (Tmax) Up to Day 33 Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
Terminal plasma half-life (T-HALF) Up to Day 33 T-Half of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
Trough observed plasma concentration (Ctrough) Up to Day 26 Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite
Apparent total body clearance (CLT/F) Up to Day 33 CLT/F of BMS-986177, aspirin, clopidogrel
Volume of distribution (Vz/F) Up to Day 33 Vz/F of BMS-986177, aspirin, clopidogrel
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States