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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01316237
First received: February 3, 2011
Last updated: March 22, 2012
Last verified: March 2012

February 3, 2011
March 22, 2012
January 2011
October 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01316237 on ClinicalTrials.gov Archive Site
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Not Provided
Hepatitis C, Chronic
  • Drug: GS-6620
    GS-6620 tablet, 50 mg QD
  • Drug: GS-6620
    GS-6620 tablet, 100 mg QD
  • Drug: GS-6620
    GS-6620 tablet, 300 mg QD
  • Drug: GS-6620
    GS-6620 tablet, 100 mg QD, Fasted
  • Drug: GS-6620
    GS-6620 tablet, 300 mg QD, Fasted
  • Drug: GS-6620
    GS-6620 tablet, 900 mg QD, Fasted
  • Drug: GS-6620 tablet, 450 mg BID
    GS-6620 tablet, 450 mg BID
  • Drug: GS-6620 tablet
    GS-6620 tablet, 900mg , BID
  • Drug: GS-6620 tablet
    GS-6620 tablet, 900 mg
  • 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
    Intervention: Drug: GS-6620
  • 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

    Intervention: Drug: GS-6620
  • 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

    Intervention: Drug: GS-6620
  • 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

    Intervention: Drug: GS-6620
  • 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

    Intervention: Drug: GS-6620
  • 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

    Intervention: Drug: GS-6620
  • 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

    Intervention: Drug: 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

    Intervention: Drug: GS-6620 tablet
  • 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.

    Intervention: Drug: GS-6620 tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
January 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01316237
GS-US-119-0101
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Stephen Rossi, PharmD Gilead Sciences
Gilead Sciences
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP