A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
- Registration Number
- NCT05409911
- Lead Sponsor
- Shionogi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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%).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-217622: Group A S-217622 Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state. S-217622: Group B S-217622 Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state. S-217622: Group C S-217622 Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state.
- Primary Outcome Measures
Name Time Method Area Under the Plasma Concentration-Time Curve (AUC) 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 Fraction Unbound in Plasma (FU) 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 Volume of Distribution (Vz/F) 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 Fraction of Dose Excreted in Urine (Feu) 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 Renal Clearance (CLR) of S-217622 0 (predose) up to 336 hours postdose on Day 1 to Day 15
- Secondary Outcome Measures
Name Time Method Number of Participants with Treatment-Emergent Adverse Events Up to Day 21
Trial Locations
- Locations (4)
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Nucleus Network
🇺🇸Saint Paul, Minnesota, United States
Orlando Clinical Research Center, Inc.
🇺🇸Orlando, Florida, United States