Clinical trial NCT01316237: A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
HCV
HCV RNA
Polymerase inhibitor
Treatment naïve
GS-6620
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

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.


Eligibility 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

Primary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability.
measure: Number of subjects with HCV RNA viral response as a measure of antiviral activity.
Secondary outcomes:
measure: Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Deland
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Houston
country: United States
facility: St. Luke Episcopal Hospital
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research, LC
state: Utah
city: Tacoma
country: United States
facility: Charles River Clinical Services Northwest
state: Washington
city: Puerto Rico
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
Study officials:
affiliation: Gilead Sciences
name: Stephen Rossi, PharmD
role: STUDY_DIRECTOR
References: