A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715479
• Other study ID #: 206222
• Secondary ID: AI468-052
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2016
• Last updated: January 17, 2017
• Start date: April 2016
• Est. completion date: May 2016

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Signed Informed Consent

2. Target population: Healthy males and females.

3. Women of child bearing potential (WOCBP) with negative serum pregnancy test

4. Women must not be breastfeeding

5. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia

2. History of frequent headaches or acute diarrhoea.

3. Any major surgery within 4 weeks of study drug administration

4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

5. History of allergy to HIV maturation and integrase inhibitors,or related compounds

6. History of smoking

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dolutegravir
Dolutegravir
• BMS955176
BMS955176

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) for DTG		Days 1 to 5 and days 15 to 21
Primary	Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG		Days 1 to 5 and days 15 to 21
Primary	Maximum observed plasma concentration (Cmax) for BMS-955176		Days 8-21
Primary	Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176		Days 8-21
Secondary	Adverse events (AEs)	The incidence of observed AEs will be tabulated and reviewed for potential significance and clinical importance.	Days 1-21; for SAEs up to 30 days post discontinuation of dosing

External Links

•   Description BMS Clinical Trial Education Resource
•   Description BMS Clinical Trial Information
•   Description FDA Safety Alerts and Recalls
•   Description Investigator Inquiry Form