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

NCT02508064 | Completed Phase 1

• 2 other identifiers: 206288AI438-054
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (11)

Part 1

EXPERIMENTAL

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

Drug: BMS-663068

Part 1: Prototype 1

EXPERIMENTAL

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

Drug: BMS-663068

Part 1: Prototype 2

EXPERIMENTAL

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

Drug: BMS-663068

Part 1: Prototype 3

EXPERIMENTAL

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

Drug: BMS-663068

Part 1: Prototype 4

EXPERIMENTAL

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

Drug: BMS-663068

Part 1: Prototype 5

EXPERIMENTAL

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

Drug: BMS-663068

Part 2

EXPERIMENTAL

BMS-663068 1 × 600 mg ER tablet formulation

Drug: BMS-663068

Part 2: Prototype 1

EXPERIMENTAL

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

Drug: BMS-663068

Part 2: Prototype 2

EXPERIMENTAL

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

Drug: BMS-663068

Part 2: Prototype 3

EXPERIMENTAL

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

Drug: BMS-663068

Part 2: Prototype 4

EXPERIMENTAL

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

Drug: BMS-663068

Interventions

BMS-663068 DRUG

BMS-663068

Part 1; Part 1: Prototype 1; Part 1: Prototype 2; Part 1: Prototype 3; Part 1: Prototype 4; Part 1: Prototype 5; Part 2; Part 2: Prototype 1; Part 2: Prototype 2; Part 2: Prototype 3; Part 2: Prototype 4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

fostemsavir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 24, 2015
• Study Start: August 3, 2015
• Primary Completion: November 5, 2015
• Study Completion: November 5, 2015
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

GB (1)