Overview

Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

Status:
Completed
Trial end date:
2015-12-23
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
ViiV Healthcare
Treatments:
BMS-955176
Criteria
Inclusion Criteria:

1. Written Informed Consent

2. Healthy male and female (not of childbearing potential) subjects as determined by
medical history, surgical history, physical examination, vital signs, ECGs, and
clinical laboratory determinations

3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1.
BMI = weight (kg)/[height(m)]

4. Women must have documented proof that they are not of childbearing potential (eg,
surgically sterile, postmenopausal with a documented follicle-stimulating hormone
(FSH) > 40 mIU/mL) and should not be breast feeding

5. Males who are sexually active with WOCBP must agree to follow instructions for
method(s) of contraception for the duration of treatment with BMS-955176 in addition
to a post-treatment completion period

Exclusion Criteria:

1. Any significant acute or chronic medical illness

2. Use of tobacco, excessive alcohol

3. Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac
disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding
disorder, a major depressive disorder within the past 6 months, peptic ulcer or
significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could
impact upon the absorption of study drug

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

5. History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides
class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole,
midazolam, or pravastatin, or to any related compounds