A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: Single Ascending Dose Cohorts GS-9620 Drug: Multiple Ascending Dose Cohorts GS-9620	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

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:

Incidence of adverse events in single and multiple doses of GS-9620 [ Time Frame: Periodically Day 1 to 6 months ] [ Designated as safety issue: Yes ]
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements

Secondary Outcome Measures:

Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods [ Time Frame: Day 1 and Day 8 ] [ Designated as safety issue: No ]
SAD cohorts: serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.

MAD cohorts: serial blood samples will be collected on Day 8 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Measurement of pharmacodynamic markers (cytokines and ISGs) [ Time Frame: Days 1, 2, 3, 5, 8 ] [ Designated as safety issue: No ]
SAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hour Post-dose, Day 2, Day 3, Day 5, Day 8

MAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hours Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15
Reduction of HCV RNA viral load from baseline [ Time Frame: Screening, Baseline, Day 8 or 15 ] [ Designated as safety issue: No ]
SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.

MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 0.3mg GS-9620	Drug: Single Ascending Dose Cohorts 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. 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.
Experimental: 1mg GS-9620	Drug: Single Ascending Dose Cohorts 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. 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.
Experimental: 2mg GS-9620	Drug: Single Ascending Dose Cohorts 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. 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.
Experimental: 4mg GS-9620	Drug: Single Ascending Dose Cohorts 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. 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.
Experimental: 0.3mg GS-9620 QW x 2 doses	Drug: Multiple Ascending Dose Cohorts 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).
Experimental: 1mg GS-9620 QW x 2 doses	Drug: Multiple Ascending Dose Cohorts 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).
Experimental: 2mg GS-9620 QW x 2 doses	Drug: Multiple Ascending Dose Cohorts 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).
Experimental: 4mg GS-9620 QW x 2 doses	Drug: Multiple Ascending Dose Cohorts 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

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

Criteria

Inclusion Criteria:

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 > 70mL/min
Negative pregnancy test at screening

Exclusion Criteria:

Pregnant or lactating subjects
Co-infection with HBV or HIV
History of Gilberts disease
Particular abnormal laboratory parameters
Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe COPD, malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
Evidence of hepatocellular carcinoma
On-going alcohol abuse
Positive uring drug screen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591668

Locations

United States, Arkansas
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
CRI Worldwide, LLC
Willingboro, New Jersey, United States, 08046
United States, New York
CliniLabs
New York, New York, United States, 10019
United States, Pennsylvania
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Utah
Lifetree Clinical Research
Salt Lake City, Utah, United States, 84106
Puerto Rico
Fundacion De Investigacion De Diego
Santurce, Puerto Rico, 00909

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01591668 History of Changes
Other Study ID Numbers:	GS-US-243-0102
Study First Received:	March 23, 2012
Last Updated:	November 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Hepatitis
Hepatitis C
Chronic HCV
HCV

Treatment Naive
Gilead
GS-9620

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 June 13, 2013