Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
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
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.
n/a
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