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Clinical Trials

MainTitle

Food Effect Study With BMS-955176

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02273947

First received: October 10, 2014
Last updated: April 13, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-955176
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Maximum observed plasma concentration (Cmax) for BMS-955176 [ Time Frame: Up to Day 4 of Period 4 ]
  • Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176 [ Time Frame: Up to Day 4 of Period 4 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176 [ Time Frame: Up to Day 4 of Period 4 ]
  • Plasma concentration at 24 hours post-dose (C24) for BMS-955176 [ Time Frame: Up to Day 4 of Period 4 ]
Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: Up to 30 days post discontinuation of dosing ]
    Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG)

Enrollment: 12
Study Start Date: October 23, 2014
Study Completion Date: August 15, 2016
Primary Completion Date: August 15, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Arm 1 (ABDC): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 2 (BCAD): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 3 (CDBA): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 4 (DACB): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 5 (EFHG): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 6 (FGEH): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 7 (GHFE): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 8 (HEGF): BMS-955176
BMS-955176 single dose by mouth for each treatment as specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 9 (IJK): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 10 (JKI): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 11 (KIJ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 12 (IKJ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 13 (JIK): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 14 (KJI): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 15 (LMN): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 16 (OPQ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 17 (PQO): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 18 (QOP): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 19 (OQP): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 20 (POQ): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Experimental: Arm 21 (QPO): BMS-955176
BMS-955176 single dose by mouth for each treatment specified
Drug: BMS-955176

Single dose by mouth for each treatment specified

Detailed Description:

Primary Purpose
Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.

Eligibility

Eligibility

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

Criteria

Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg)/[Height (m)]2
  • Men and women, ages 18 to 50 years, inclusive
  • Women must not be of childbearing potential, must not be breastfeeding


Exclusion Criteria:
  • Any significant acute or chronic medical illness
  • History of cardiac disease or clinically significant cardiac arrhythmias
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • Any major surgery within 4 weeks of study drug administration
  • Any gastrointestinal surgery (including cholecystectomy) that could impact upon the
absorption of study drug

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: NCT02273947

Locations

United Kingdom
GSK Investigational Site
Ruddington Fields, Nottinghamshire, United Kingdom, NG11 6JS

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02273947   History of Changes  
Other Study ID Numbers: 206221  
Study First Received: October 10, 2014  
Last Updated: April 13, 2017  

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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.