Trial Details

Not Recruiting
Basic Information
Clinical ID c2402
Identifier ACTRN12621000612819
Trial Title A Phase 1, Dose-Escalation Study in Healthy Volunteers to Evaluate the Pharmacokinetics, Safety, and Tolerability of GS-1427 Following Single and Multiple Dosing
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions Inflammatory bowel disease; Inflammatory bowel disease;Oral and Gastrointestinal - Inflammatory bowel disease
Interventions Two parts: - Part A: 5 cohorts Single Ascending Dose TBD during the study - Part B: 5 cohorts Multiple ascending dose based on Part A Mode of administration - oral capsule The adherence is completed by the site staff watching the participant take the drug and swallow it and then doing a visual check of their mouth to ensure it has been swallowed. Part A Cohort 1: GS-1427 single dose on Day 1 - 20mg Cohort 2: GS-1427 single dose on Day 1 - Upto 60mg Cohort 3: GS-1427 single dose on Day 1 - Upto 200mg Cohort 3: GS-1427 single dose on Day 8 - Upto 200mg Cohort 4: GS-1427 single dose on Day 1 - Upto 500mg Cohort 5: GS-1427 single dose on Day 1 - Upto 100mg Part B Cohort 6: GS-1427 twice daily for 14 days - Dose TBD Cohort 7: GS-1427 twice daily for 14 days - Dose TBD Cohort 8: GS-1427 twice daily for 14 days - Dose TBD Cohort 9: GS-1427 twice daily for 14 days - Dose TBD Cohort 10: GS-1427 once daily for 14 days - Dose TBD
Participant Information
Sponsor Gilead Sciences
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date 2023-01-30
Completion Date 2022-03-17