A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: S-217622


Participation Criteria
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Eligibility Criteria
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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: Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6) 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 exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-217622: Group A<br>Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state. | Drug: S-217622<br>* Tablet for oral administration<br>|
| Experimental: S-217622: Group B<br>Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state. | Drug: S-217622<br>* Tablet for oral administration<br>|
| Experimental: S-217622: Group C<br>Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state. | Drug: S-217622<br>* Tablet for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fraction Unbound in Plasma (FU) of S-217622 |  | 0 (predose) up to 336 hours postdose on Day 1 to Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-Emergent Adverse Events |  | Up to Day 21 |