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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02273947
Other study ID # 206221
Secondary ID
Status Completed
Phase Phase 1
First received October 10, 2014
Last updated April 13, 2017
Start date October 23, 2014
Est. completion date August 15, 2016

Study information

Verified date April 2017
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the impact of a light meal, a standard meal, and a high fat meal on the PK of BMS-955176 MC tablet at a dose of 180 mg, relative to fasted conditions.


Description:

Primary Purpose

Other: This study will assess the impact of a light meal, a standard meal, and a high fat meal on the pharmacokinetics (PK) of BMS-955176 micronized crystalline (MC) tablet at a dose of 180 mg relative to fasted conditions.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 15, 2016
Est. primary completion date August 15, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BMS-955176
Single dose by mouth for each treatment specified

Locations

Country Name City State
United Kingdom GSK Investigational Site Ruddington Fields Nottinghamshire

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 plasma concentration (Cmax) for BMS-955176 Up to Day 4 of Period 4
Primary Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] for BMS-955176 Up to Day 4 of Period 4
Primary Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-955176 Up to Day 4 of Period 4
Primary Plasma concentration at 24 hours post-dose (C24) for BMS-955176 Up to Day 4 of Period 4
Secondary Safety and tolerability Safety and tolerability measured by incidence of AEs, serious AEs (SAEs), AEs leading to discontinuation and death, marked abnormalities in clinical laboratory tests, viral sign measurements, ECGs, and physical examination Adverse Events (AEs), Electrocardiogram (ECG) Up to 30 days post discontinuation of dosing
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