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

Purpose

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.

Condition	Intervention	Phase
HCV Infection	Drug: GS-5885 Drug: Placebo	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Number of subjects reporting an adverse event or experiencing a laboratory abnormality [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline [ Time Frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure of GS-5885 plasma concentration over time [ Time Frame: Assessed up to Study Day 14 following administration of multiple doses of GS-5885 or placebo for 3 days ] [ Designated as safety issue: No ]
Emergence of viral resistance [ Time Frame: Up to 48 weeks following Study Day 14 ] [ Designated as safety issue: No ]

Enrollment:	71
Study Start Date:	August 2010
Study Completion Date:	December 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cohort 1 GS-5885 (3 mg), once daily or matching placebo, once daily	Drug: GS-5885 tablet, oral, 3 mg once daily for 3 days Drug: Placebo tablet, oral, once daily for 3 days
Active Comparator: Cohort 2 GS-5885 (10 mg), once daily or matching placebo, once daily	Drug: GS-5885 tablet, oral, 10 mg once daily for 3 days Drug: Placebo tablet, oral, once daily for 3 days
Active Comparator: Cohort 3 GS-5885 (30 mg), once daily or matching placebo, once daily	Drug: GS-5885 tablet, oral, 30 mg once daily for 3 days Drug: Placebo tablet, oral, once daily for 3 days
Active Comparator: Cohort 4 GS-5885 ( up to 90 mg), once daily or matching placebo, once daily	Drug: GS-5885 tablet, oral, up to 90 mg once daily for 3 days Drug: Placebo tablet, oral, once daily for 3 days
Active Comparator: Cohort 5 GS-5885 (up to 90 mg), once daily or matching placebo, once daily	Drug: GS-5885 tablet, oral, up to 90 mg once daily for 3 days Drug: Placebo tablet, oral, once daily for 3 days
Active Comparator: Cohort 6 (optional) GS-5885 (up to 90 mg), once daily or matching placebo, once daily	Drug: GS-5885 tablet, oral, up to 90 mg once daily for 3 days Drug: Placebo tablet, oral, once daily for 3 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01193478

Locations

United States, California

Anaheim, California, United States, 92801

Cypress, California, United States, 90630

National City, California, United States, 91950
United States, District of Columbia

Washington, District of Columbia, United States, 20010
United States, Florida

Deland, Florida, United States, 32720

Miami, Florida, United States, 33169

Orlando, Florida, United States, 32809
United States, Missouri

St. Louis, Missouri, United States, 63104
United States, Oregon

Portland, Oregon, United States, 97239
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19139
United States, Texas

Houston, Texas, United States, 77030

San Antonio, Texas, United States, 78215
United States, Washington

Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Diana Brainard, MD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01193478 History of Changes
Other Study ID Numbers:	GS-US-256-0102
Study First Received:	August 31, 2010
Last Updated:	January 18, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Hepatitis C
HCV RNA
multiple ascending dose

NS5A
GS-5885
chronic genotype 1 HCV infection

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013