A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: GS-6620 Drug: GS-6620 tablet, 450 mg BID Drug: GS-6620 tablet	Phase 1

Study Type:	Interventional
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

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:

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.

Estimated Enrollment:	90
Study Start Date:	January 2011
Study Completion Date:	January 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1 (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	Drug: GS-6620 GS-6620 tablet, 50 mg QD
Cohort 2 (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	Drug: GS-6620 GS-6620 tablet, 100 mg QD
Cohort 3 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	Drug: GS-6620 GS-6620 tablet, 300 mg QD
Cohort 4 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	Drug: GS-6620 GS-6620 tablet, 100 mg QD, Fasted
Cohort 5 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	Drug: GS-6620 GS-6620 tablet, 300 mg QD, Fasted
Cohort 6 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	Drug: GS-6620 GS-6620 tablet, 900 mg QD, Fasted
Cohort 7 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	Drug: GS-6620 tablet, 450 mg BID GS-6620 tablet, 450 mg BID
Cohort 9 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	Drug: GS-6620 tablet GS-6620 tablet, 900mg , BID
Cohort 11 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.	Drug: GS-6620 tablet GS-6620 tablet, 900 mg

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316237

Locations

United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Axis Clinical Trials
Los Angeles, California, United States, 90057
United States, Florida
Avail Clinical Research, LLC
Deland, Florida, United States, 32720
University of Florida - Gainesville
Gainesville, Florida, United States, 32608
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Orlando Immunology Center
Orlando, Florida, United States, 32803
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
United States, Pennsylvania
CRI Worldwide
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
St. Luke Episcopal Hospital
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Utah
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States, 84106
United States, Washington
Charles River Clinical Services Northwest
Tacoma, Washington, United States, 98418
Puerto Rico
Fundacion De Investigacion De Diego
Puerto Rico, Puerto Rico, 00927

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director:

Stephen Rossi, PharmD

Gilead Sciences

More Information

No publications provided

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01316237 History of Changes
Other Study ID Numbers:	GS-US-119-0101
Study First Received:	February 3, 2011
Last Updated:	March 22, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Hepatitis C
HCV
HCV RNA

Polymerase inhibitor
Treatment naïve
GS-6620

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013