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
Inclusion Criteria5
- Have the ability to understand and sign a written informed consent form (ICF), which must
- be obtained prior to initiation of study procedures
- Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued
- days prior to the first dose of study drug.
- Have a calculated body mass index (BMI) of > 19.0 and < 30.0 kg/m2 at screening
Exclusion Criteria6
- Positive serum pregnancy test
- Breastfeeding female
- Male subjects who plan to donate sperm from clinic admission (eg, Day -1), throughout the
- study period, and/or within 14 days following the last dose of study drug
- Have received any investigational study drug within 30 days prior to study dosing
- Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety, or a positive drug or alcohol test at screening or baseline
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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