A Study to Assess S-217622 in Participants With Renal Impairment and Healthy Participants

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

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.

Key facts

Study ID

NCT05363215

Run by

Shionogi

People needed

32

Starts

2022-08-10

Expected to finish

2023-04-12

Last updated by the study team

2023-04-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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%).

You may not qualify if…

• 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.

Where it is running

• Clinical Pharmacology of Miami, LLC — Miami, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Orlando Clinical Research Center, Inc. — Orlando, Florida, United States
• Nucleus Network — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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