A Phase 1 Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of GS-5718 and to Evaluate the Effect of GS-5718 on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
Gilead Sciences
32 participants
Sep 24, 2021
Interventional
Conditions
Summary
The primary objective of this study is to evaluate the effect of CYP3A/P-gp inhibition on the pharmacokinetics of GS-5718 and the effect of GS-5718 on the pharmacokinetics of OATP/BCRP substrates.
Eligibility
Plain Language Summary
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Interventions
Cohort 1: GS-5718: Period 1 Day 1 (Dose 50 mg), Period 2 Day 5 (Dose 50mg), Oral Tablet Itraconazole: Period 2: 200 mg, oral solution, twice daily, Day 1 then 200 mg, oral solution, once daily, Days 2-9 Cohort 2: GS-5718: Period 2 (GS-5718) Days 1-10, Oral tablet 130 mg Rosuvastatin: 10 mg Period 1 (ROS only) Day 1, Period 2 (ROS and GS-5718) Day 8, Oral tablet Strategies used to monitor adherence: drug tablet return,
Locations(1)
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ACTRN12621000785808