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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Clopidogrel; Other: Placebo (for BMS-986177); Drug: Aspirin; Drug: BMS-986177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03698513

CV010-034

Details and patient eligibility

About

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

Enrollment: 113 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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113 participants in 9 patient groups, including a placebo group

BMS-986177 + Aspirin + Clopidogrel (Part 1)

Experimental group

Description:

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)

Treatment:

Drug: Aspirin

Drug: BMS-986177

Drug: Clopidogrel

BMS-986177 (Part 1)

Experimental group

Description:

BMS-986177 200 mg capsule twice daily (days 1-5)

Treatment:

Drug: BMS-986177

BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)

Placebo Comparator group

Description:

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)

Treatment:

Drug: Aspirin

Drug: Clopidogrel

Other: Placebo (for BMS-986177)

BMS-986177 (Part 2)

Experimental group

Description:

BMS-986177 200 mg capsule twice daily (days 1-5)

Treatment:

Drug: BMS-986177

BMS-986177 placebo + Clopidogrel (Part 2)

Placebo Comparator group

Description:

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)

Treatment:

Drug: Clopidogrel

Other: Placebo (for BMS-986177)

BMS-986177 + Clopidogrel (Part 2)

Experimental group

Description:

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)

Treatment:

Drug: BMS-986177

Drug: Clopidogrel

BMS-986177 (Part 3)

Experimental group

Description:

BMS-986177 200 mg capsule twice daily (days 1-5)

Treatment:

Drug: BMS-986177

BMS-986177 placebo + Aspirin (Part 3)

Placebo Comparator group

Description:

BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)

Treatment:

Drug: Aspirin

Other: Placebo (for BMS-986177)

BMS-986177 + Aspirin (Part 3)

Experimental group

Description:

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

Treatment:

Drug: Aspirin

Drug: BMS-986177