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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02508064

Enrollment

Registered

2015-07-24

Start date

2015-08-03

Completion date

2015-11-05

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

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.

Interventions

DRUGBMS-663068

BMS-663068

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026