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

Phase 1

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: BMS-663068

• Registration Number: NCT02508064
• Lead Sponsor: ViiV Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Study Start: 2015-08-03
• Primary Completion: 2015-11-05
• Study Completion: 2015-11-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2: Prototype 2	BMS-663068	BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)
Part 1	BMS-663068	BMS-663068 1 × 600 mg extended-release (ER) tablet formulation
Part 2: Prototype 1	BMS-663068	BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)
Part 1: Prototype 3	BMS-663068	BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)
Part 2: Prototype 3	BMS-663068	BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)
Part 1: Prototype 1	BMS-663068	BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)
Part 1: Prototype 2	BMS-663068	BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)
Part 1: Prototype 4	BMS-663068	BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)
Part 2	BMS-663068	BMS-663068 1 × 600 mg ER tablet formulation
Part 1: Prototype 5	BMS-663068	BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)
Part 2: Prototype 4	BMS-663068	BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529	Day 1 to Day 4 of each period
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529	Day 1 to Day 4 of each period
Maximum observed concentration (Cmax) of BMS-626529	Day 1 to Day 4 of each period

Secondary Outcome Measures

Name	Time	Method
Safety of BMS-663068 will be measured by incidence of Adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation;, and results of clinical laboratory tests, vital signs, 12-lead ECGs, and Physical examination (PE)	Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing
Tolerability of BMS-663068 will be measured by incidence of AEs, SAEs, and AEs leading to discontinuation; and results of clinical laboratory tests, vital signs and 12-lead ECGs	Day 1 to Day 4 of each period; for SAEs up to 30 days post discontinuation of dosing

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Nottingham, United Kingdom