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

A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 From Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi-Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: BMS-663068

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; BMS-663068 1 × 600 mg extended-release (ER) tablet formulation	Drug: BMS-663068; BMS-663068
Experimental: Part 1: Prototype 1; BMS-663068 600 mg ER low-dose tablet formulation (Prototype 1)	Drug: BMS-663068; BMS-663068
Experimental: Part 1: Prototype 2; BMS-663068 600 mg ER low-dose tablet formulation (Prototype 2)	Drug: BMS-663068; BMS-663068
Experimental: Part 1: Prototype 3; BMS-663068 600 mg ER low-dose tablet formulation (Prototype 3)	Drug: BMS-663068; BMS-663068
Experimental: Part 1: Prototype 4; BMS-663068 600 mg ER low-dose tablet formulation (Prototype 4)	Drug: BMS-663068; BMS-663068
Experimental: Part 1: Prototype 5; BMS-663068 600 mg ER low-dose tablet formulation (Prototype 5)	Drug: BMS-663068; BMS-663068
Experimental: Part 2; BMS-663068 1 × 600 mg ER tablet formulation	Drug: BMS-663068; BMS-663068
Experimental: Part 2: Prototype 1; BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 1)	Drug: BMS-663068; BMS-663068
Experimental: Part 2: Prototype 2; BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 2)	Drug: BMS-663068; BMS-663068
Experimental: Part 2: Prototype 3; BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 3)	Drug: BMS-663068; BMS-663068
Experimental: Part 2: Prototype 4; BMS-663068 600 mg ER prototype multi-particulate formulation (Prototype 4)	Drug: BMS-663068; BMS-663068

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax) of BMS-626529	Day 1 to Day 4 of each period
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2015
• Primary Completion (Actual): November 5, 2015
• Study Completion (Actual): November 5, 2015

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Fostemsavir
• Other Study ID Numbers: 206288; AI438-054 (Other Identifier: Bristol-Myers Squibb)