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

HCV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01193478
• Other study ID #: GS-US-256-0102
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2010
• Last updated: January 18, 2013
• Start date: August 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronically infected with HCV genotype 1

• HCV treatment-naïve

• Not co-infected with HIV or HBV

• HCV RNA viral load of at least 100,000 IU/mL

• BMI 19 to 35 kg/m2

• Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

• History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

• Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma

• Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype

• Subjects with known, current use of amphetamines and/or cocaine; subjects taking methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HCV Infection
• Hepatitis C
• Infection

Intervention

Drug:
• GS-5885
tablet, oral, 3 mg once daily for 3 days
• Placebo
tablet, oral, once daily for 3 days
• GS-5885
tablet, oral, 10 mg once daily for 3 days
• Placebo
tablet, oral, once daily for 3 days
• GS-5885
tablet, oral, 30 mg once daily for 3 days
• Placebo
tablet, oral, once daily for 3 days
• GS-5885
tablet, oral, up to 90 mg once daily for 3 days
• Placebo
tablet, oral, once daily for 3 days
• GS-5885
tablet, oral, up to 90 mg once daily for 3 days
• Placebo
tablet, oral, once daily for 3 days
• GS-5885
tablet, oral, up to 90 mg once daily for 3 days
• Placebo
tablet, oral, once daily for 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects reporting an adverse event or experiencing a laboratory abnormality		Safety and tolerability assessments will be performed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days	Yes
Primary	Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline		Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days	No
Secondary	Measure of GS-5885 plasma concentration over time		Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days	No
Secondary	Emergence of viral resistance		Up to 48 weeks following Study Day 14	No