The primary objective of this study is to evaluate the pharmacokinetics (PK) of selonsertib in participants with impaired hepatic function relative to matched, healthy controls.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
6 mg tablets administered orally in fed state
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
San Antonio, Texas, United States
Pharmacokinetic (PK) Parameter: AUCinf of Selonsertib and Its Metabolite GS-607509
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
PK Parameter: AUClast of Selonsertib and Its Metabolite GS-607509
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
PK Parameter: Cmax of Selonsertib and Its Metabolite GS-607509
Cmax is defined as the maximum concentration of drug.
Time frame: 0 (predose), 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, and 120 hours postdose on Day 1. Additional PK samples were collected at the Day 10 and 14 follow-up visits approximately the same time as the Day 1 predose sample.
Percentage of Participants Experiencing Treatment-Emergent Study Drug-related Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs were defined as events that met one of the following criteria: 1) Any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; or 2) Any AEs leading to premature discontinuation of study drug.
Time frame: Day 1 plus 30 days
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Percentage of Participants Experiencing Any Treatment-Emergent and Grade ≥ 3 Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from predose at any postdose visit, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study drug. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent. Severity grades were defined based on modified Common Terminology Criteria for Adverse Events (CTCAE) Laboratory Abnormality and Adverse Event Severity Grading, where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. The most severe graded abnormality from all tests was counted for each participant.
Time frame: Day 1 plus 30 days