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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316237
• Other study ID #: GS-US-119-0101
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2011
• Last updated: March 22, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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., a-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

Study Design

N/A

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• GS-6620
GS-6620 tablet, 50 mg QD
• GS-6620
GS-6620 tablet, 100 mg QD
• GS-6620
GS-6620 tablet, 300 mg QD
• GS-6620
GS-6620 tablet, 100 mg QD, Fasted
• GS-6620
GS-6620 tablet, 300 mg QD, Fasted
• GS-6620
GS-6620 tablet, 900 mg QD, Fasted
• GS-6620 tablet, 450 mg BID
GS-6620 tablet, 450 mg BID
• GS-6620 tablet
GS-6620 tablet, 900mg , BID
• GS-6620 tablet
GS-6620 tablet, 900 mg

Locations

Country	Name	City	State
Puerto Rico	Fundacion De Investigacion De Diego	Puerto Rico
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Avail Clinical Research, LLC	Deland	Florida
United States	University of Florida - Gainesville	Gainesville	Florida
United States	St. Luke Episcopal Hospital	Houston	Texas
United States	Axis Clinical Trials	Los Angeles	California
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	Lifetree Clinical Research, LC	Salt Lake City	Utah
United States	Alamo Medical Research	San Antonio	Texas
United States	Saint Louis University	St. Louis	Missouri
United States	Charles River Clinical Services Northwest	Tacoma	Washington

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	Number of subjects with adverse events as a measure of safety and tolerability.
Primary	Number of subjects with HCV RNA viral response as a measure of antiviral activity.
Secondary	Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.