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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000785808

Enrollment

Registered

2021-06-22

Start date

2021-09-24

Completion date

2022-02-02

Last updated

2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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,

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

- 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 90 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 criteria

- 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

Outcome results