Clinical Trials

MainTitle

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

This study has been completed
Sponsor
ViiV Healthcare


Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02578277

First received: October 15, 2015
Last updated: July 11, 2018
Last Verified: July 2018
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV Infections

Drug : CYP and transporter probe substrates
Drug : BMS-955176
Drug : BMS-955176 plus CYP and transporter probe substrates
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Cmax (maximum observed concentration) [ Time Frame: Days 1 to 18 ]
  • 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 ]
  • AUC(INF), area under the concentration-time curve from time zero extrapolated to infinite time [ Time Frame: Days 1 to 18 ]

Enrollment: 59
Study Start Date: November 9, 2015
Study Completion Date: December 23, 2015
Primary Completion Date: December 23, 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Single sequence, 3-period DDI (drug-drug interaction)
Single sequence
Drug: CYP and transporter probe substrates

Cocktail of CYP (cytochrome P450) and transporter probe substrates

Drug: BMS-955176

BMS-955176

Drug: BMS-955176 plus CYP and transporter probe substrates

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02578277

Locations

United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744

Sponsors and Collaborators

ViiV Healthcare

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02578277   History of Changes  
Other Study ID Numbers: 206294  
  AI468-063  
Study First Received: October 15, 2015  
Last Updated: July 11, 2018  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on July 19, 2018
This information is provided by ClinicalTrials.gov.