RecruitingPhase 1ACTRN12621000785808

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


Sponsor

Gilead Sciences

Enrollment

32 participants

Start Date

Sep 24, 2021

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This is a drug interaction study in healthy volunteers, testing how the investigational compound GS-5718 — a drug candidate being developed by Gilead Sciences — behaves in the body when taken alongside other medications. Specifically, the study looks at whether itraconazole (an antifungal drug that inhibits certain liver enzymes) changes how much GS-5718 gets into the bloodstream, and whether GS-5718 itself affects the levels of rosuvastatin (a cholesterol-lowering drug) in the body. Understanding these drug interactions is a critical part of making sure a new medication is safe to use in patients who might be taking other drugs at the same time. This type of pharmacokinetics study involves carefully timed blood samples after doses of each drug. You may be eligible if you are a healthy adult between 18 and 45 with a BMI between 19 and 30, are a non-smoker (and have not used nicotine for at least 90 days), and have not participated in another drug study within the past 30 days. Pregnant or breastfeeding women, people with substance use issues, and men planning to donate sperm during the study are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

SA, Australia

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ACTRN12621000785808


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