Status:
COMPLETED
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 B...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT02277600
Start Date
November 5 2014
End Date
January 12 2015
Last Update
January 24 2018
Active Locations (1)
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1
GSK Investigational Site
San Antonio, Texas, United States, 78209