A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
- Registration Number
- NCT05363215
- Lead Sponsor
- Shionogi
- Brief Summary
The objective of this study is to measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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 Renal Impairment
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Participants that are not undergoing dialysis must have mild, moderate, or severe renal impairment based upon their Modification of Diet in Renal Disease (MDRD) creatinine clearance estimate (estimated glomerular filtration rate [eGFR]) calculated at the Screening visit:
- Mild renal impairment: 60 to 89 milliliters per minute (mL/min)/1.73 m^2
- Moderate renal impairment: 30 to 59 mL/min/1.73 m^2
- Severe renal impairment: No lower limit of eGFR, <30 mL/min
-
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
- Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by MDRD, must be normal (ie, eGFR > 90 mL/min/1.73 m^2).
- Matched to each participant with moderate renal impairment with respect to sex, age (± 5 years), and BMI (± 10%).
Exclusion Criteria
- Participants with life expectancy less than 3 months.
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, 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.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S-217622: Group C S-217622 Participants with severe renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state. S-217622: Group A S-217622 Participants with mild renal 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 renal impairment will receive a single dose of S-217622 on Day 1, in a fasted state. S-217622: Group D S-217622 Participants with normal renal function will receive a single dose of S-217622 on Day 1, in a fasted state.
- Primary Outcome Measures
Name Time Method Time to Maximum Plasma Concentration (Tmax) 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 Maximum Observed Plasma Concentration (Cmax) 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 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 S217622 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
Orlando Clinical Research Center, Inc.
🇺🇸Orlando, Florida, United States
Advanced Pharma CR, LLC
🇺🇸Miami, Florida, United States
Nucleus Network
🇺🇸Saint Paul, Minnesota, United States