Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
NCT ID: NCT02578277
Last Updated: 2018-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2015-11-09
2015-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single sequence, 3-period DDI (drug-drug interaction)
Single sequence
CYP and transporter probe substrates
Cocktail of CYP (cytochrome P450) and transporter probe substrates
BMS-955176
BMS-955176
BMS-955176 plus CYP and transporter probe substrates
BMS-955176 plus the cocktail of CYP and transporter probe substrates
Interventions
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CYP and transporter probe substrates
Cocktail of CYP (cytochrome P450) and transporter probe substrates
BMS-955176
BMS-955176
BMS-955176 plus CYP and transporter probe substrates
BMS-955176 plus the cocktail of CYP and transporter probe substrates
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
Yes
Sponsors
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ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Austin, Texas, United States
Countries
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Other Identifiers
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AI468-063
Identifier Type: OTHER
Identifier Source: secondary_id
206294
Identifier Type: -
Identifier Source: org_study_id
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