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

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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

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus Drug: GS-5816 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
(N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 2
(N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 3
(N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 4
(N = 10, genotype 1a): up to 150 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 5
(N = 10, genotype 2): up to 400 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 6
(N = 10, genotype 2): up to 400 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 7
(N = 10, genotype 3): up to 400 mg GS-5816 or placebo QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of GS-5816

Experimental: Cohort 8
(N = 10, genotype 4/5/6): up to 400 mg GS-5816 QD fasted for 3 days
Drug: GS-5816
3 days of monotherapy of 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
Drug: GS-5816
3 days of monotherapy of 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
Drug: GS-5816
3 days of monotherapy of 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
Drug: GS-5816
3 days of monotherapy of 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
Drug: GS-5816
3 days of monotherapy of GS-5816




Primary Outcome Measures :
  1. Safety [ Time Frame: 48 weeks ]
    Number of participants with Adverse Events, laboratory abnormalities and ECG abnormalities.

  2. Antiviral Activity [ Time Frame: 48 weeks ]
    Change from baseline in HCV RNA


Secondary Outcome Measures :
  1. Viral Dynamics [ Time Frame: 48 weeks ]
    Maximal reduction over time in HCV RNA and proportion of subject with HCV RNA < LLOQ.

  2. 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

  3. Pharmacokinetics [ Time Frame: 48 weeks ]
    Pharmacokinetics parameters will include Cmax, Tmax, AUC, T1/2

  4. Pharmacodynamics [ Time Frame: 48 weeks ]
    Changes in HCV NS5A sequence following administration of GS-5816



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740791


Locations
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United States, California
West Coast Clinical Trials, LLC
Costa Mesa, California, United States, 92626
United States, Florida
Avail Clinical Research, LLC
Deland, Florida, United States, 32720
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Missouri
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, New Jersey
CRI Worldwide, LLC
Marlton, New Jersey, United States, 08053
United States, Pennsylvania
CRI Worldwide, LLC
Philadelphia, Pennsylvania, United States, 19139
United States, Tennessee
New Orleans Center for Clinical Research-Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Washington
Charles River Clinical Services Northwest, Inc.
Tacoma, Washington, United States, 98418
Puerto Rico
Fundacion De Investigacion De Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: John McNally, PhD Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01740791     History of Changes
Other Study ID Numbers: GS-US-281-0102
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014

Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Genotype 1
Genotype 2
Genotype 3
Genotype 4
Genotype 5
Genotype 6
Liver Disease

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Velpatasvir
Anti-Infective Agents