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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01193478
First received: August 31, 2010
Last updated: January 18, 2013
Last verified: January 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Hepatitis
Hepatitis C
Infection
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014