NCT00725803

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV

A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Activity of GS-9450, a Caspase Inhibitor, in Subjects With Chronic Hepatitis C (GS-US-227-0102)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies how the body processes a drug), and initial activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.

Detailed description

Approximately 32 subjects will receive GS 9450 or placebo for 14 consecutive days. Eight subjects will receive treatment within each of four dosing cohorts; 6 randomized to receive GS 9450 and two randomized to placebo: Cohort 1: GS 9450 10 mg or placebo given daily x 14 days Cohort 2: GS 9450 40 mg or placebo given daily x 14 days Cohort 3: GS 9450 80 mg or placebo given daily x 14 days If further characterization of the activity profile is deemed necessary, an additional cohort at a lower dose (5 mg) may be enrolled: Cohort 4: GS 9450 5 mg or placebo given daily x 14 days Each cohort will be conducted sequentially. Advancement to higher dose cohorts is dependent upon satisfactory safety and tolerability profiles of the preceding cohort as determined by Sponsor review (conducted in consultation with the Lead Investigator\[s\]). Progression to Cohort 4 (5 mg dose strength) will not require a safety review of Cohort 3 (80 mg dose strength); screening and randomization for Cohort 4 may begin immediately after fully enrolling Cohort 3. Alternatively, if a dose-response relationship is apparent in review of the blinded activity data from the first three cohorts, the final 5 mg cohort may be omitted.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	GS-9450	GS-9450 capsules administered orally once daily
DRUG	GS-9450 Placebo	Placebo to match GS-9450 administered orally once daily

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-10-01
• Completion: 2009-03-01
• First posted: 2008-07-31
• Last updated: 2014-06-19

Locations

11 sites across 3 countries: United States, Germany, Netherlands