Clinical trial NCT03369002: Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
Official title: A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Hepatic Impairment
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 5 days
measure: Time to reach maximum concentration (Tmax)
timeFrame: 5 days
measure: Area under of the curve (AUC0-t and AUC0-∞)
timeFrame: 5 days
measure: Elimination of half-life (t1/2)
timeFrame: 5 days
measure: Apparent terminal elimination rate constant (λz)
timeFrame: 5 days
measure: Total body clearance (CL/F)
timeFrame: 5 days
measure: Volume of distribution (Vz/F)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: DaVita Clinical Research
state: Colorado
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Knoxville
country: United States
facility: Vrg & Noccr
state: Tennessee
Study officials:
References: