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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01316237

Enrollment

Registered

2011-03-16

Start date

2011-01-31

Completion date

2012-01-31

Last updated

2012-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, HCV, HCV RNA, Polymerase inhibitor, Treatment naïve, GS-6620

Brief 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.

Interventions

DRUGGS-6620

GS-6620 tablet, 50 mg QD

DRUGGS-6620 tablet, 450 mg BID

GS-6620 tablet, 450 mg BID

DRUGGS-6620 tablet

GS-6620 tablet, 900mg , BID

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.	—

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026