A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
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
1 other identifier
interventional
33
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
Shorter than P25 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 20, 2013
CompletedFirst Posted
Study publicly available on registry
March 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 29, 2013
August 1, 2013
5 months
March 20, 2013
August 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic parameters of GS-5816
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Up to one year
Secondary Outcomes (1)
Incidences of adverse events and laboratory abnormalities
Up to one year
Study Arms (2)
Cohort 1
EXPERIMENTAL(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816.
Cohort 2
EXPERIMENTAL(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic (\> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
You may not qualify if:
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (6)
Investigational Site
Miami, Florida, 33014, United States
Investigational Site
Miami, Florida, 33169, United States
Investigational Site
Orlando, Florida, 32806, United States
Investigational Site
Orlando, Florida, 32809, United States
Investigational Site
San Antonio, Texas, 78215, United States
Investigational Site
San Juan, Puerto Rico, 00927, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diana Brainard, M.D.
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2013
First Posted
March 26, 2013
Study Start
March 1, 2013
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
August 29, 2013
Record last verified: 2013-08