A Phase 1 Study to Evaluate the Effect of Itraconazole on thePharmacokinetics of GS-5718 and to Evaluate the Effect ofGS-5718 on the Pharmacokinetics of Rosuvastatin in HealthySubjects

Phase 1

Recruiting

• Conditions: Inflammatory Diseases; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12621000785808
• Lead Sponsor: Gilead Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-22
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified