Back to resultsA Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Primary Purpose
HCV Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GS-5885
Placebo
GS-5885
Placebo
GS-5885
Placebo
GS-5885
Placebo
GS-5885
Placebo
GS-5885
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HCV Infection focused on measuring Hepatitis C, HCV RNA, multiple ascending dose, NS5A, GS-5885, chronic genotype 1 HCV infection
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6 (optional)
Arm Description
GS-5885 (3 mg), once daily or matching placebo, once daily
GS-5885 (10 mg), once daily or matching placebo, once daily
GS-5885 (30 mg), once daily or matching placebo, once daily
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Outcomes
Primary Outcome Measures
Number of subjects reporting an adverse event or experiencing a laboratory abnormality
Antiviral activity measures: measured by change in plasma HCV RNA levels form baseline
Secondary Outcome Measures
Measure of GS-5885 plasma concentration over time
Emergence of viral resistance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01193478
Brief Title
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection
Keywords
Hepatitis C, HCV RNA, multiple ascending dose, NS5A, GS-5885, chronic genotype 1 HCV infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Active Comparator
Arm Description
GS-5885 (3 mg), once daily or matching placebo, once daily
Arm Title
Cohort 2
Arm Type
Active Comparator
Arm Description
GS-5885 (10 mg), once daily or matching placebo, once daily
Arm Title
Cohort 3
Arm Type
Active Comparator
Arm Description
GS-5885 (30 mg), once daily or matching placebo, once daily
Arm Title
Cohort 4
Arm Type
Active Comparator
Arm Description
GS-5885 ( up to 90 mg), once daily or matching placebo, once daily
Arm Title
Cohort 5
Arm Type
Active Comparator
Arm Description
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Arm Title
Cohort 6 (optional)
Arm Type
Active Comparator
Arm Description
GS-5885 (up to 90 mg), once daily or matching placebo, once daily
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
tablet, oral, 3 mg once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, oral, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
tablet, oral, 10 mg once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, oral, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
tablet, oral, 30 mg once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, oral, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
tablet, oral, up to 90 mg once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, oral, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
tablet, oral, up to 90 mg once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, oral, once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
GS-5885
Intervention Description
tablet, oral, up to 90 mg once daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet, oral, once daily for 3 days
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Emergence of viral resistance
Time Frame
Up to 48 weeks following Study Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Brainard, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23877691
Citation
Wong KA, Worth A, Martin R, Svarovskaia E, Brainard DM, Lawitz E, Miller MD, Mo H. Characterization of Hepatitis C virus resistance from a multiple-dose clinical trial of the novel NS5A inhibitor GS-5885. Antimicrob Agents Chemother. 2013 Dec;57(12):6333-40. doi: 10.1128/AAC.02193-12. Epub 2013 Jul 22.
Results Reference
derived
Learn more about this trial
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
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