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

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508064
• Other study ID #: 206288
• Secondary ID: AI438-054
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2015
• Last updated: September 7, 2017
• Start date: August 3, 2015
• Est. completion date: November 5, 2015

Study information

• Verified date: September 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 5, 2015
• Est. primary completion date: November 5, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-663068
BMS-663068

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) of BMS-626529		Day 1 to Day 4 of each period
Primary	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
Primary	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	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
Secondary	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