Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
Key facts
- Study ID
- NCT03369002
- Run by
- Gilead Sciences
- People needed
- 32
- Starts
- 2017-11-27
- Expected to finish
- 2018-05-15
- Last updated by the study team
- 2018-05-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Must have given written informed consent (signed and dated) and any authorizations required by local law.
- Willing to be confined to CRU for the entire duration required by the protocol.
- Male or female, between 18 and 80 years of age.
- Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
- Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
You may not qualify if…
- Pregnant or lactating women.
- Treatment with another investigational drug or device within 30 days prior to study drug administration.
- Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
- Inability to swallow medication.
- Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
- Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
Where it is running
- DaVita Clinical Research — Lakewood, Colorado, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- DaVita Clinical Research — Minneapolis, Minnesota, United States
- Vrg & Noccr — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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