Hepatic Impairment
Conditions
Brief summary
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with control participants with normal hepatic function.
Interventions
DRUGS-217622
Tablet for oral administration
Sponsors
Shionogi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight ≥50 kilograms (kg) and body mass index (BMI) within the range of ≥18.5 to \<38.0 kilogram-meter squared (kg/m\^2) at the Screening visit. Participants With Hepatic Impairment * A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography \[CT\] scan, magnetic resonance imaging \[MRI\], or ultrasonography). * Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility: 1. Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6) 2. Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9) * A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit. Healthy Participants * Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).
Exclusion criteria
* History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function. * Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * Breast cancer within the past 10 years. * Participant with poor venous access. Other inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction Unbound in Plasma (FU) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Maximum Observed Plasma Concentration (Cmax) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Time to Maximum Plasma Concentration (Tmax) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Area Under the Plasma Concentration-Time Curve (AUC) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Terminal Elimination Half-Life (t1/2,z) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Terminal Elimination Rate Constant (λz) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Mean Residence Time (MRT) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Apparent Total Clearance (CL/F) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Apparent Volume of Distribution (Vz/F) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Renal Clearance (CLR) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
| Fraction of Dose Excreted in Urine (Feu) of S-217622 | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Treatment-Emergent Adverse Events | Up to Day 21 |
Countries
United States
Outcome results
None listed