NCT01193478

A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Escalating, Multiple, Oral Doses of GS 5885 in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the clinic for the initial 5 days of the study.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	GS-5885	tablet, oral, 3 mg once daily for 3 days
DRUG	Placebo	tablet, oral, once daily for 3 days
DRUG	GS-5885	tablet, oral, 10 mg once daily for 3 days
DRUG	Placebo	tablet, oral, once daily for 3 days
DRUG	GS-5885	tablet, oral, 30 mg once daily for 3 days
DRUG	Placebo	tablet, oral, once daily for 3 days
DRUG	GS-5885	tablet, oral, up to 90 mg once daily for 3 days
DRUG	Placebo	tablet, oral, once daily for 3 days
DRUG	GS-5885	tablet, oral, up to 90 mg once daily for 3 days
DRUG	Placebo	tablet, oral, once daily for 3 days
DRUG	GS-5885	tablet, oral, up to 90 mg once daily for 3 days
DRUG	Placebo	tablet, oral, once daily for 3 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-01-01
• Completion: 2011-12-01
• First posted: 2010-09-02
• Last updated: 2013-01-21

Locations

13 sites across 1 country: United States