Healthy Volunteers
Conditions
Brief summary
This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel
Interventions
DRUGBMS-986177
BMS-986177 capsule
OTHERPlacebo (for BMS-986177)
BMS-986177 placebo match capsule
DRUGClopidogrel
Clopidogrel tablet
DRUGAspirin
Aspirin tablet
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with physical examination abnormalities | Up to Day 33 |
| Incidence of Adverse Events (AEs) | Up to Day 33 |
| Incidence of Serious Adverse Events (SAEs) | Up to Day 95 |
| 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 12-lead electrocardiogram (ECG) abnormalities | Up to Day 33 |
| Number of participants with clinical laboratory abnormalities | Up to Day 33 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed