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

NCT01193478 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2013-01-21

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Diana Brainard, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-01-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193478 on ClinicalTrials.gov