Food Effect Study With BMS-955176

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

An Open-Label, Randomized, Crossover Adaptive Design Study to Assess the Effect of Food on the Pharmacokinetics of BMS-955176 Administered as a Micronized Crystalline Tablet in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273947
• Other study ID #: 206221
• 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
• 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

Related Conditions & MeSH terms

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

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