Back to resultsA Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GS-5816
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C (HCV) Infection, Moderate Hepatic Impairment, Severe Hepatic Impairment
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic (> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
Exclusion Criteria:
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
Sites / Locations
- Investigational Site
- Investigational Site
- Investigational Site
- Investigational Site
- Investigational Site
- Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.
(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters of GS-5816
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Secondary Outcome Measures
Incidences of adverse events and laboratory abnormalities
The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01817985
Brief Title
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Official Title
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Hepatitis C (HCV) Infection, Moderate Hepatic Impairment, Severe Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.
Intervention Type
Drug
Intervention Name(s)
GS-5816
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of GS-5816
Description
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Incidences of adverse events and laboratory abnormalities
Description
The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.
Time Frame
Up to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic (> 6 months), hepatic impairment.
In the opinion of the Investigator, be in good health.
Exclusion Criteria:
Severe hepatic encephalopathy.
Prior placement of a portosystemic shunt.
Hepatorenal or hepatopulmonary syndrome.
Suspicion of hepatocellular carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Brainard, M.D.
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Investigational Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
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