Relative Bioavailability Study With BMS-955176

NCT ID: NCT02095886

Last Updated: 2017-09-11

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-25

Study Completion Date

2014-07-07

Brief Summary

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The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.

Detailed Description

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Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed

Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F)

BMS-955176 single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-955176

Intervention Type DRUG

BMS-955176

Interventions

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BMS-955176

BMS-955176

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / \[height (m)\]2
* Men and women, ages 18 to 50 years, inclusive
* Women must not be of childbearing potential, must not be breastfeeding

Exclusion Criteria

* Any significant acute or chronic medical illness
* History of cardiac disease or clinically significant cardiac arrhythmias
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2013-004896-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI468-034

Identifier Type: OTHER

Identifier Source: secondary_id

206740

Identifier Type: -

Identifier Source: org_study_id

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