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Clinical Trials

MainTitle

Relative Bioavailability Study With BMS-955176

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02095886

First received: March 21, 2014
Last updated: September 7, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

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: Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Maximum observed plasma concentration (Cmax) of BMS-955176 [ Time Frame: Days 1-4 of Periods 1, 2, 3 and 4 ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176 [ Time Frame: Days 1-4 of Periods 1, 2, 3 and 4 ]
  • Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176 [ Time Frame: Days 1-4 of Periods 1, 2, 3 and 4 ]
Secondary Outcome Measures:
  • Time of maximum observed plasma concentration (Tmax) of BMS-955176 [ Time Frame: Days 1-4 of Periods 1, 2, 3 and 4 ]
  • Terminal plasma half-life (T-HALF) of BMS-955176 [ Time Frame: Days 1-4 of Periods 1, 2, 3 and 4 ]
  • Apparent total body clearance (CLT/F) of BMS-955176 [ Time Frame: Days 1-4 of Periods 1, 2, 3 and 4 ]
  • Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations [ Time Frame: Up to Period 4/Day 4 (discharge) ]

Enrollment: 47
Study Start Date: March 25, 2014
Study Completion Date: July 7, 2014
Primary Completion Date: July 7, 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Experimental: Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)
BMS-955176 single dose by mouth as specified
Drug: BMS-955176

BMS-955176

Detailed Description:

Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed

Eligibility

Eligibility

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

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:

  • Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (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: NCT02095886

Locations

United Kingdom
GSK Investigational Site
Nottingham, 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: NCT02095886   History of Changes  
Other Study ID Numbers: 206740  
  2013-004896-10  
  AI468-034  
Study First Received: March 21, 2014  
Last Updated: September 7, 2017  

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

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.