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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-03

Study Completion Date

2015-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

NCT02805556

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

Relative Bioavailability Study With BMS-955176

NCT02095886

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529

NCT02164045

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects

NCT02059031

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

NCT02666053

Infection, Human Immunodeficiency Virus

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection, Human Immunodeficiency Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 1: Prototype 1

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 1: Prototype 2

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 1: Prototype 3

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 1: Prototype 4

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 1: Prototype 5

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 2

BMS-663068 1 × 600 mg ER tablet formulation

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 2: Prototype 1

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 2: Prototype 2

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 2: Prototype 3

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Part 2: Prototype 4

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-663068

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes