A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/18/2019 |
| Start Date: | October 4, 2018 |
| End Date: | February 2, 2019 |
| Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information |
| Email: | Clinical.Trials@bms.com |
| Phone: | please email: |
A Randomized, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986177 (an Oral Anti-thrombotic) With Single and Dual Antiplatelet Therapy (Aspirin and Clopidogrel) in Healthy Participants
This study will investigate the safety and interaction of BMS-986177 in healthy volunteers,
when administered with Aspirin and/or Clopidogrel
when administered with Aspirin and/or Clopidogrel
Inclusion Criteria:
- Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Women not of childbearing potential (must have documented proof).
- Males who are sexually active with women of childbearing potential must agree to
follow instructions for method(s) of contraception for the duration of treatment with
BMS-986177 for a total of 92 days after completion of study treatment. Male
participants must additionally refrain from sperm donation during this time.
Exclusion Criteria:
- Women of childbearing potential or who are breastfeeding.
- 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.
- Any major surgery within 4 weeks of study treatment administration or planned within 2
weeks after completion of the study.
- Use of tobacco- or nicotine-containing products (including, but not limited to,
cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine
lozenges, or nicotine gum) within 6 months prior to study treatment administration.
- History of any adverse reaction to anticoagulants or antiplatelet agents that resulted
in excessive bleeding, requiring medication intervention.
Other protocol-defined inclusion/exclusion criteria could apply.
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