A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277600
• Other study ID #: 206285
• Secondary ID: AI438-044
• Status: Completed
• Phase: Phase 1
• First received: October 27, 2014
• Last updated: January 22, 2018
• Start date: November 5, 2014
• Est. completion date: January 12, 2015

Study information

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

Clinical Trial Summary

This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 12, 2015
• Est. primary completion date: January 12, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male and female

• Nonsmoking subjects

• Ages 18 to 50 years

• Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive

• Women of childbearing potential

• Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion

Exclusion Criteria:

• Any history of acute or chronic medical and surgical illness.

• Personal of family history of hemophilia A or B

• Other protocol defined exclusion criteria could apply

Related Conditions & MeSH terms

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

Intervention

Drug:
• BMS-663068
BMS-663068
• Darunavir
Darunavir
• Cobicistat
Cobicistat

Locations

Country	Name	City	State
United States	GSK Investigational Site	San Antonio	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
Other	Safety as assessed by adverse events and other physical parameters	Collection of adverse events and other physical parameters to assess safety and tolerability	From dosing (Day 1) to Day 14
Primary	Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529	In the presence or absence of multiple doses of DRV/COBI or COBI	predose and up to 12 hours post dose on Days 4 and 14