Relative Bioavailability Study With BMS-955176

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-955176

Study type: Interventional

Funder types: Industry

Identifiers

NCT02095886

206740

2013-004896-10 (EudraCT Number)

AI468-034 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 47 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 8 patient groups

Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176

Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)

Experimental group

Description:

BMS-955176 single dose by mouth as specified

Treatment:

Drug: BMS-955176