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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT03698513

Run by

Bristol-Myers Squibb

People needed

113

Starts

2018-10-04

Expected to finish

2019-02-19

Last updated by the study team

2021-09-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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