A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection
1 other identifier
interventional
51
2 countries
11
Brief Summary
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2012
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 13, 2013
August 1, 2013
9 months
March 23, 2012
August 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events in single and multiple doses of GS-9620
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
Periodically Day 1 to 6 months
Secondary Outcomes (3)
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
Day 1 and Day 8
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Days 1, 2, 3, 5, 8
Reduction of hepatitis C (HCV) RNA viral load from baseline
Screening, Baseline, Day 8 or 15
Study Arms (8)
0.3mg GS-9620
EXPERIMENTAL1mg GS-9620
EXPERIMENTAL2mg GS-9620
EXPERIMENTAL4mg GS-9620
EXPERIMENTAL0.3mg GS-9620 QW x 2 doses
EXPERIMENTAL1mg GS-9620 QW x 2 doses
EXPERIMENTAL2mg GS-9620 QW x 2 doses
EXPERIMENTAL4mg GS-9620 QW x 2 doses
EXPERIMENTALInterventions
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Eligibility Criteria
You may qualify if:
- Males and Females 18-65 years old
- Chronic HCV infection for at least 6 months, treatment naive
- HCV Viral load \> 100,000 IU/mL at Screening
- Monoinfection with HCV 1 genotype
- Hepatitis B surface antigen negative
- Screening ECG without clinically significant abnormalities
- BMI 18-33 kg/m\^2
- Creatinine clearing \> 70 mL/min
- Negative pregnancy test at screening
You may not qualify if:
- Pregnant or lactating subjects
- Co-infection with hepatitis B virus (HBV) or HIV
- History of Gilberts disease
- Particular abnormal laboratory parameters
- Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
- Evidence of hepatocellular carcinoma
- On-going alcohol abuse
- Positive uring drug screen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (11)
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
CRI Worldwide, LLC
Willingboro, New Jersey, 08046, United States
CliniLabs
New York, New York, 10019, United States
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Fundacion De Investigacion De Diego
Santurce, PR, 00909, Puerto Rico
Related Publications (1)
Lawitz E, Gruener D, Marbury T, Hill J, Webster L, Hassman D, Nguyen AH, Pflanz S, Mogalian E, Gaggar A, Massetto B, Subramanian GM, McHutchison JG, Jacobson IM, Freilich B, Rodriguez-Torres M. Safety, pharmacokinetics and pharmacodynamics of the oral toll-like receptor 7 agonist GS-9620 in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2015;20(7):699-708. doi: 10.3851/IMP2845. Epub 2014 Aug 8.
PMID: 25105516DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2012
First Posted
May 4, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 13, 2013
Record last verified: 2013-08