Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-663068

Study type: Interventional

Funder types: Industry

Identifiers

NCT02508064

206288

AI438-054 (Other Identifier)

Details and patient eligibility

About

This 2-part study will determine the bioavailability of BMS-626529 in healthy subjects from prototype low dose extended release formulations (Part 1) of BMS-663068 and prototype extended release multi-particulate formulations (Part 2) of BMS-663068 relative to 600 mg extended release tablet of BMS-663068.

Enrollment: 27 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:

• Males and females, 18 to 50 years of age, inclusive
• Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, PE findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
• Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (performed for all females; minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Evidence of organ dysfunction or any clinically significant deviation from normal in PE, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

• Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat:

  i) PR ≥ 210 msec ii) QRS ≥ 120 msec iii) QT ≥ 500 msec and iv) QTcF ≥ 450 msec

• Exposure to any investigational drug or placebo within 12 weeks of study drug administration

• Positive blood screen for hepatitis C antibody (HCV Ab), hepatitis B surface antigen (HBsAg), or HIV-1 and HIV-2 antibody

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 11 patient groups

Part 1

Experimental group

Description:

BMS-663068 1 × 600 mg extended-release (ER) tablet formulation

Treatment:

Drug: BMS-663068

Part 1: Prototype 1

Experimental group

Description:

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)

Treatment:

Drug: BMS-663068

Part 1: Prototype 2

Experimental group

Description:

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)

Treatment:

Drug: BMS-663068

Part 1: Prototype 3

Experimental group

Description:

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)

Treatment:

Drug: BMS-663068

Part 1: Prototype 4

Experimental group

Description:

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)

Treatment:

Drug: BMS-663068

Part 1: Prototype 5

Experimental group

Description:

BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)

Treatment:

Drug: BMS-663068

Part 2

Experimental group

Description:

BMS-663068 1 × 600 mg ER tablet formulation

Treatment:

Drug: BMS-663068

Part 2: Prototype 1

Experimental group

Description:

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)

Treatment:

Drug: BMS-663068

Part 2: Prototype 2

Experimental group

Description:

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)

Treatment:

Drug: BMS-663068

Part 2: Prototype 3

Experimental group

Description:

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)

Treatment:

Drug: BMS-663068

Part 2: Prototype 4

Experimental group

Description:

BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)

Treatment:

Drug: BMS-663068