NCT01316237

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

9 months

First QC Date

February 3, 2011

Last Update Submit

March 22, 2012

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis CHCVHCV RNAPolymerase inhibitorTreatment naïveGS-6620

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.

Study Arms (9)

Cohort 1

OTHER

(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

Cohort 2

OTHER

(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

Cohort 3

OTHER

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

Cohort 4

OTHER

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

Cohort 5

OTHER

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

Cohort 6

OTHER

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

Cohort 7

OTHER

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

Cohort 9

OTHER

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

Cohort 11

OTHER

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

Interventions

GS-6620DRUG

GS-6620 tablet, 50 mg QD

Cohort 1
GS-6620 tablet, 450 mg BIDDRUG

GS-6620 tablet, 450 mg BID

Cohort 7
GS-6620 tabletDRUG

GS-6620 tablet, 900mg , BID

Cohort 9

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Axis Clinical Trials

Los Angeles, California, 90057, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

University of Florida - Gainesville

Gainesville, Florida, 32608, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

St. Luke Episcopal Hospital

Houston, Texas, 77030, United States

Location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Lifetree Clinical Research, LC

Salt Lake City, Utah, 84106, United States

Location

Charles River Clinical Services Northwest

Tacoma, Washington, 98418, United States

Location

Fundacion De Investigacion De Diego

San Juan, PR, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

GS-6620BID protein, human

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephen Rossi, PharmD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

March 16, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

US(12)PR(1)