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Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic HCV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740791
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE November 26, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date March 10, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Safety [ Time Frame: 48 weeks ]
    Number of participants with Adverse Events, laboratory abnormalities and ECG abnormalities.
  • Antiviral Activity [ Time Frame: 48 weeks ]
    Change from baseline in HCV RNA
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2012)
  • Viral Dynamics [ Time Frame: 48 weeks ]
    Maximal reduction over time in HCV RNA and proportion of subject with HCV RNA < LLOQ.
  • Characterization of NSA5a coding region in HCV following dose administration of GS-5816 [ Time Frame: 48 weeks ]
    Sequence changes in the NS5A coding region of HCV following multiple dose administration of GS-5816 and for up to 48 weeks thereafter
  • Pharmacokinetics [ Time Frame: 48 weeks ]
    Pharmacokinetics parameters will include Cmax, Tmax, AUC, T1/2
  • Pharmacodynamics [ Time Frame: 48 weeks ]
    Changes in HCV NS5A sequence following administration of GS-5816
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic HCV Infection
Official Title  ICMJE Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-5816 in Subjects With Chronic Hepatitis C Virus Infection
Brief Summary The goal of this study is to assess the safety, tolerability, antiviral activity and pharmacokinetics of GS-5816 in HCV treatment naïve subjects with genotypes 1-6.
Detailed Description Administration of GS-5816 will be limited to 3 consecutive days to minimize the potential development of resistance. All subjects will be monitored for up to 48 weeks post-dose to determine the persistence of viral mutations. Twelve cohorts are planned for the examination; within each cohort subjects will receive QD doses of GS-5816 with safety, antiviral activity and pharmacokinetic assessments evaluated at specified time-points during the study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Virus
Intervention  ICMJE Drug: GS-5816
3 days of monotherapy of GS-5816
Study Arms  ICMJE
  • Experimental: Cohort 1
    (N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 2
    (N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 3
    (N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 4
    (N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 5
    (N = 10, genotype 2): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 6
    (N = 10, genotype 2): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 7
    (N = 10, genotype 3): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 8
    (N = 10, genotype 4/5/6): up to 400 mg GS-5816 QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 9
    (N = 10, genotype 1a, 1b, 2, 3 or 4/5/6): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 10
    (N = 10, genotype 1a, 1b, 2, 3 or 4/5/6): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 11
    (N = 10, genotype 1a, 1b, 2, 3 or 4/5/6): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
  • Experimental: Cohort 12
    (N = 10, genotype 1a, 1b, 2, 3 or 4/5/6): up to 400 mg GS-5816 or placebo QD fasted for 3 days
    Intervention: Drug: GS-5816
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2014)
94
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2012)
120
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HCV treatment-naïve adult subjects (18-65 years of age)with chronic HCV infection and plasma HCV RNA ≥ 5 log10 IU/mL at screening
  • Agree to use protocol defined precautions against pregnancy

Exclusion Criteria:

  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  • Evidence of cirrhosis
  • Evidence of current drug abuse
  • Screening laboratory results outside the protocol specified requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740791
Other Study ID Numbers  ICMJE GS-US-281-0102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John McNally, PhD Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2014

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