Status:
COMPLETED
A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants
Lead Sponsor:
Shionogi
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
Key Trial Info
Start Date :
August 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05363215
Start Date
August 10 2022
End Date
April 12 2023
Last Update
April 24 2023
Active Locations (4)
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1
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
2
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
3
Orlando Clinical Research Center, Inc.
Orlando, Florida, United States, 32809
4
Nucleus Network
Saint Paul, Minnesota, United States, 55114