Overview

A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

Status:
Completed

Trial end date:
2016-12-01

Target enrollment:
0

Participant gender:
All

Summary

This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Rifampin

Criteria

Inclusion Criteria:

1. Signed Informed Consent

2. Healthy men and women (not of child bearing potential) as determined by medical
history, surgical history, physical examination, vital signs, electrocardiogram (ECG),
and clinical laboratory tests including coagulation parameters.

3. Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney
function.

4. Women participants must have documented proof that they are not of childbearing
potential.

5. Men who are sexually active with WOCBP must agree to follow instructions for method(s)
of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3
days) plus 90 days (duration of sperm turnover) for a total of 93 days after
completion of BMS-986177 treatment.

Exclusion Criteria:

1. Any significant acute or chronic medical illness, including any other condition listed
as a contraindication in the rifampin package insert

2. History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux
disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract
infections, hypermenorrhea and recurrent candida infections, abnormal bleeding,
history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.

3. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm,
drug or alcohol abuse and use of tobacco or nicotine containing products in past six
months.

4. Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECGs, or clinical laboratory determinations beyond
what is consistent with the target population

5. History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds