Relative Bioavailability Study With BMS-955176

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

Assessment of BMS-955176 Bioavailability From a Micronized Crystalline Tablet Relative to a Spray-Dried Dispersion Suspension and Assessment of Additional Experimental Formulations Relative to the Micronized Crystalline Tablet in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095886
• Other study ID #: 206740
• Secondary ID: 2013-004896-10AI
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2014
• Last updated: September 7, 2017
• Start date: March 25, 2014
• Est. completion date: July 7, 2014

Study information

• Verified date: September 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 7, 2014
• Est. primary completion date: July 7, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• BMS-955176
BMS-955176

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Nottingham

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) of BMS-955176		Days 1-4 of Periods 1, 2, 3 and 4
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176		Days 1-4 of Periods 1, 2, 3 and 4
Primary	Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176		Days 1-4 of Periods 1, 2, 3 and 4
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-955176		Days 1-4 of Periods 1, 2, 3 and 4
Secondary	Terminal plasma half-life (T-HALF) of BMS-955176		Days 1-4 of Periods 1, 2, 3 and 4
Secondary	Apparent total body clearance (CLT/F) of BMS-955176		Days 1-4 of Periods 1, 2, 3 and 4
Secondary	Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations		Up to Period 4/Day 4 (discharge)