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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02508064
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 27
• Location: 1
• Arms: 11
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: BMS-663068	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: 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
• Actual Study Start Date: Aug 3, 2015
• Actual Primary Completion Date: Nov 5, 2015
• Actual Study Completion Date: Nov 5, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum observed concentration (Cmax) of BMS-626529 [Day 1 to Day 4 of each period]

2. 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]

3. 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

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Nottingham		United Kingdom	NG11 6JS

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02508064
• Other Study ID Numbers: 206288; AI438-054
• First Posted: Jul 24, 2015
• Last Update Posted: Sep 11, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Fostemsavir

Study Results

No Results Posted as of Sep 11, 2017