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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591668
• Other study ID #: GS-US-243-0102
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2012
• Last updated: August 12, 2013
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 > 70 mL/min

• Negative pregnancy test at screening

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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.
• 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).

Locations

Country	Name	City	State
Puerto Rico	Fundacion De Investigacion De Diego	Santurce
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Kansas City Gastroenterology and Hepatology	Kansas City	Missouri
United States	Woodland International Research Group	Little Rock	Arkansas
United States	CliniLabs	New York	New York
United States	Orlando Clinical Research Center	Orlando	Florida
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Alamo Medical Research	San Antonio	Texas
United States	CRI Worldwide, LLC	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods	Single ascending dose (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.; Multiple ascending 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.	Day 1 and Day 8	No
Secondary	Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])	SAD cohorts: Whole blood and serum for pharmacodynamic (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	Days 1, 2, 3, 5, 8	No
Secondary	Reduction of hepatitis C (HCV) RNA viral load from baseline	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.	Screening, Baseline, Day 8 or 15	No