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OpenTrials
Completed

NCT Number: NCT02578277

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

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written Informed Consent
  • 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
  • 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)]
  • 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
  • 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

  • Any significant acute or chronic medical illness
  • Use of tobacco, excessive alcohol
  • 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
  • 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
  • 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

Treatment and study plan

CYP and transporter probe substrates

Drug

Cocktail of CYP (cytochrome P450) and transporter probe substrates

BMS-955176

Drug

BMS-955176

BMS-955176 plus CYP and transporter probe substrates

Drug

BMS-955176 plus the cocktail of CYP and transporter probe substrates

Primary outcomes

  1. Cmax (maximum observed concentration)

    Time frame: Days 1 to 18

  2. AUC(0-T), area under the concentration-time curve from time zero to the time of the last quantifiable concentration

    Time frame: Days 1 to 18

  3. AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time

    Time frame: Days 1 to 18

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Registry information

Official study title

Effects of BMS-955176 on the Single-dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2015
Registry last updated
Jul 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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