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Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment

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: NCT02002767
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study is to evaluate the single-dose pharmacokinetics (PK), safety, and tolerability of GS-5816 in participants with severe renal impairment using matched healthy participants as a control group.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment
Study Start Date : December 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Participants with renal impairment
Participants with severe renal impairment will receive a single dose of GS-5816.
Drug: GS-5816
GS-5816 100 mg (2 x 50 mg tablets) administered orally

Active Comparator: Participants with normal renal function
Participants with normal renal function will receive a single dose of GS-5816.
Drug: GS-5816
GS-5816 100 mg (2 x 50 mg tablets) administered orally




Primary Outcome Measures :
  1. Plasma pharmacokinetics (PK) parameters of GS-5816 as measured by AUClast, AUCinf, and Cmax [ Time Frame: Baseline to Day 6 ]
    • AUClast is defined as the concentration of drug from time zero to the last observable concentration
    • AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time)
    • Cmax is defined as the maximum concentration of drug


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Baseline to Day 6 plus 30 days ]
    The incidence of adverse events will be summarized.

  2. Measurement of vital signs [ Time Frame: Baseline to Day 6 plus 30 days ]
    Information on vital signs, including electrocardiograms (ECGs), will be collected and summarized.

  3. Incidence of laboratory abnormalities [ Time Frame: Baseline to Day 6 plus 30 days ]
    The incidence of laboratory abnormalities will be summarized.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • General good health with stable chronic kidney disease in Severe Renal Impairment Group
  • Screening labs within defined thresholds
  • Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

Exclusion Criteria:

  • Females who are pregnant or nursing, or males who have a pregnant partner
  • Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV
  • History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with subject treatment and/or adherence to the protocol

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): NCT02002767


Locations
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United States, Florida
Miami, Florida, United States, 33014
Orlando, Florida, United States, 32809
United States, Minnesota
St. Paul, Minnesota, United States, 55114
United States, Texas
San Antonio, Texas, United States, 78215
New Zealand
Christchurch, New Zealand, 08011
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Luisa Stamm, MD, PhD Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02002767    
Other Study ID Numbers: GS-US-281-1056
2013-004113-41 ( EudraCT Number )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Hepatitis C
Renal Insufficiency
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Kidney Diseases
Urologic Diseases
Velpatasvir
Antiviral Agents
Anti-Infective Agents