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Food Effect Study With BMS-955176

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273947
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Brief Summary:
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 or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-955176 Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Actual Study Start Date : October 23, 2014
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : August 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) for BMS-955176 [ Time Frame: Up to Day 4 of Period 4 ]
  2. 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 ]
  3. 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 ]
  4. Plasma concentration at 24 hours post-dose (C24) for BMS-955176 [ Time Frame: Up to Day 4 of Period 4 ]

Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273947


Locations
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United Kingdom
GSK Investigational Site
Ruddington Fields, Nottinghamshire, United Kingdom, NG11 6JS
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02273947     History of Changes
Other Study ID Numbers: 206221
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
BMS-955176
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents