NCT01231542

Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will be a phase I, open label, two arm, fixed sequence crossover study to investigate the effect of rifampin and rifabutin on the steady state pharmacokinetics (PK) of GSK1349572 and the safety and tolerability of GSK1349572 and rifamycin co-administration. Subjects enrolled in Arm 1 will receive GSK1349572 50 mg once daily for 7 days, GSK1348572 50 mg twice daily for 7 days, and GSK1349572 50 mg twice daily in combination with rifampin 600 mg once daily for 14 days. Subjects in Arm 2 will receive GSK1349572 50 mg once daily for 7 days and GSK1349572 50 mg once daily in combination with rifabutin 300 mg once daily for 14 days. Serial PK sampling will be completed following the last dose of each treatment. Safety and tolerability will be assessed throughout the study through assessment of adverse events (AEs), and clinical laboratory tests. This study will be conducted at one center in the US with healthy adult male and female subjects.

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	GSK1349572	GSK1349572 is an experimental drug for the treatment of HIV. GSK1349572 is in the integrase inhibitor class. It is not yet approved by the FDA.
DRUG	Rifampin	Rifampin is approved by the FDA for the treatment of tuberculosis.
DRUG	Rifabutin	Rifabutin is approved by the FDA for the treatment of tuberculosis.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2010-11-01
• Last updated: 2017-06-08

Locations

1 site across 1 country: United States