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

• Status: Completed
• Trial end date: 2019-02-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Aspirin; Clopidogrel; Ticlopidine

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.