A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S-217622: Group A Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state. |
Drug: S-217622
Tablet for oral administration
|
| Experimental: S-217622: Group B Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state. |
Drug: S-217622
Tablet for oral administration
|
| Experimental: S-217622: Group C Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state. |
Drug: S-217622
Tablet for oral administration
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of Participants with Treatment-Emergent Adverse Events [Up to Day 21]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shionogi
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2127T1213