Back to resultsA Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GS-6620
GS-6620
GS-6620
GS-6620
GS-6620
GS-6620
GS-6620 tablet, 450 mg BID
GS-6620 tablet
GS-6620 tablet
Sponsored by
About this trial
This is an interventional trial for Hepatitis C, Chronic focused on measuring Hepatitis C, HCV, HCV RNA, Polymerase inhibitor, Treatment naïve, GS-6620
Eligibility Criteria
Inclusion Criteria:
- Adult subjects (18-60 years of age or up to 64 years of age with approval)
- Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
- HCV treatment naïve
- Estimated creatinine clearance ≥ 80 mL/min,
- QTcF interval ≤ 450 msec, QRS duration < 100 msec, PR interval < 220 msec,
- Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
- Eligible subjects must also be HCV treatment-naïve.
Exclusion Criteria:
- Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL or by any other standard of care measure)
- Urine drug screen positive for illicit/illegal drugs
- ALT and AST levels > 5 times the upper limit of the normal range (ULN)
- Direct bilirubin > ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × ULN and albumin < 3.5 g/dL) are not eligible for study participation.
- Subjects with an absolute neutrophil count (ANC) < 1,000 cells/mm3 (< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) < 11 g/dL,
- Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or another HCV genotype (other than type 1 for Cohorts 1-5 and type 2 or 3 for Cohort 6) are not eligible for study participation.
- Evidence of hepatocellular carcinoma
- Any sign of decompensated liver disease, including prothrombin time ≥ 1.5 X ULN, platelets < 100,000/mm3 or albumin < 3.5 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Sites / Locations
- Advanced Clinical Research Institute
- Axis Clinical Trials
- Avail Clinical Research, LLC
- University of Florida - Gainesville
- Orlando Immunology Center
- Orlando Clinical Research Center
- Saint Louis University
- CRI Worldwide
- St. Luke Episcopal Hospital
- Alamo Medical Research
- Lifetree Clinical Research, LC
- Charles River Clinical Services Northwest
- Fundacion De Investigacion De Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Other
Other
Other
Other
Other
Other
Other
Other
Other
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Cohort 7
Cohort 9
Cohort 11
Arm Description
(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 50 mg GS-6620 or placebo QD in the morning with food [total daily dose (TDD) = 50 mg] for 5 days
(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS-6620 or placebo QD in the morning with food (TDD = 100 mg) for 5 days
Cohort 3 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning with food (TDD = 300 mg) for 5 days
Cohort 4 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS 6620 or placebo QD in the morning without food (TDD = 100 mg) for 5 days
Cohort 5 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning without food (TDD = 300 mg) for 5 days
Cohort 6 (N = 10, genotype 2 or genotype 3): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo QD in the morning without food (TDD = 900 mg) for 5 days
Cohort 7 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 450 mg GS 6620 or placebo, administered BID with food (TDD = 900 mg) for 5 days
Cohort 9 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo BID in the with food (TDD = 1800 mg) for 5 days
Cohort 11 (N = 10, genotype 1 : (Active drug: 8, Matching Placebo: 2) Up to 450 mg GS-6620 or placebo as an oral solution, BID, 12 hours apart in the fasted state, 2 hours after a meal (up to TDD = up to 900 mg) for 5 days.
Outcomes
Primary Outcome Measures
Number of subjects with adverse events as a measure of safety and tolerability.
Number of subjects with HCV RNA viral response as a measure of antiviral activity.
Secondary Outcome Measures
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01316237
Brief Title
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
Official Title
A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
Brief Summary
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, HCV, HCV RNA, Polymerase inhibitor, Treatment naïve, GS-6620
7. Study Design
Study Phase
Phase 1
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Other
Arm Description
(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 50 mg GS-6620 or placebo QD in the morning with food [total daily dose (TDD) = 50 mg] for 5 days
Arm Title
Cohort 2
Arm Type
Other
Arm Description
(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
100 mg GS-6620 or placebo QD in the morning with food (TDD = 100 mg) for 5 days
Arm Title
Cohort 3
Arm Type
Other
Arm Description
Cohort 3 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
300 mg GS 6620 or placebo QD in the morning with food (TDD = 300 mg) for 5 days
Arm Title
Cohort 4
Arm Type
Other
Arm Description
Cohort 4 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
100 mg GS 6620 or placebo QD in the morning without food (TDD = 100 mg) for 5 days
Arm Title
Cohort 5
Arm Type
Other
Arm Description
Cohort 5 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
300 mg GS 6620 or placebo QD in the morning without food (TDD = 300 mg) for 5 days
Arm Title
Cohort 6
Arm Type
Other
Arm Description
Cohort 6 (N = 10, genotype 2 or genotype 3): (Active drug: 8, Matching Placebo: 2)
900 mg GS 6620 or placebo QD in the morning without food (TDD = 900 mg) for 5 days
Arm Title
Cohort 7
Arm Type
Other
Arm Description
Cohort 7 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
450 mg GS 6620 or placebo, administered BID with food (TDD = 900 mg) for 5 days
Arm Title
Cohort 9
Arm Type
Other
Arm Description
Cohort 9 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
900 mg GS 6620 or placebo BID in the with food (TDD = 1800 mg) for 5 days
Arm Title
Cohort 11
Arm Type
Other
Arm Description
Cohort 11 (N = 10, genotype 1 : (Active drug: 8, Matching Placebo: 2)
Up to 450 mg GS-6620 or placebo as an oral solution, BID, 12 hours apart in the fasted state, 2 hours after a meal (up to TDD = up to 900 mg) for 5 days.
Intervention Type
Drug
Intervention Name(s)
GS-6620
Intervention Description
GS-6620 tablet, 50 mg QD
Intervention Type
Drug
Intervention Name(s)
GS-6620
Intervention Description
GS-6620 tablet, 100 mg QD
Intervention Type
Drug
Intervention Name(s)
GS-6620
Intervention Description
GS-6620 tablet, 300 mg QD
Intervention Type
Drug
Intervention Name(s)
GS-6620
Intervention Description
GS-6620 tablet, 100 mg QD, Fasted
Intervention Type
Drug
Intervention Name(s)
GS-6620
Intervention Description
GS-6620 tablet, 300 mg QD, Fasted
Intervention Type
Drug
Intervention Name(s)
GS-6620
Intervention Description
GS-6620 tablet, 900 mg QD, Fasted
Intervention Type
Drug
Intervention Name(s)
GS-6620 tablet, 450 mg BID
Intervention Description
GS-6620 tablet, 450 mg BID
Intervention Type
Drug
Intervention Name(s)
GS-6620 tablet
Intervention Description
GS-6620 tablet, 900mg , BID
Intervention Type
Drug
Intervention Name(s)
GS-6620 tablet
Intervention Description
GS-6620 tablet, 900 mg
Primary Outcome Measure Information:
Title
Number of subjects with adverse events as a measure of safety and tolerability.
Title
Number of subjects with HCV RNA viral response as a measure of antiviral activity.
Secondary Outcome Measure Information:
Title
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects (18-60 years of age or up to 64 years of age with approval)
Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
HCV treatment naïve
Estimated creatinine clearance ≥ 80 mL/min,
QTcF interval ≤ 450 msec, QRS duration < 100 msec, PR interval < 220 msec,
Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
Eligible subjects must also be HCV treatment-naïve.
Exclusion Criteria:
Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL or by any other standard of care measure)
Urine drug screen positive for illicit/illegal drugs
ALT and AST levels > 5 times the upper limit of the normal range (ULN)
Direct bilirubin > ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × ULN and albumin < 3.5 g/dL) are not eligible for study participation.
Subjects with an absolute neutrophil count (ANC) < 1,000 cells/mm3 (< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) < 11 g/dL,
Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or another HCV genotype (other than type 1 for Cohorts 1-5 and type 2 or 3 for Cohort 6) are not eligible for study participation.
Evidence of hepatocellular carcinoma
Any sign of decompensated liver disease, including prothrombin time ≥ 1.5 X ULN, platelets < 100,000/mm3 or albumin < 3.5 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Rossi, PharmD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Avail Clinical Research, LLC
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University of Florida - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
CRI Worldwide
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
St. Luke Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Lifetree Clinical Research, LC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Charles River Clinical Services Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
Facility Name
Fundacion De Investigacion De Diego
City
Puerto Rico
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
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