Status:
RECRUITING
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
Lead Sponsor:
Shionogi
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Renal Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or ren...
Eligibility Criteria
Inclusion
- Key
- Considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram during the screening period and on Day -1.
- Participants With Severe, Moderate, and Mild Renal Impairment not on HD (Group A, D and E): Participants that are not undergoing HD and have mild, moderate, or severe renal impairment based upon the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula (estimated glomerular filtration rate \[eGFR\]) and the participant's body surface area (BSA) calculated at the screening visit.
- Participants With Renal Impairment Requiring HD (Group B): Receiving stable HD at least 3 times a week for at least 6 months prior to screening
- Participants With Normal Renal Function: 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 the 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 milliliters/minute).
- Key
Exclusion
- Participants with life expectancy less than or equal to 3 months.
- History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, 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 based on the judgment of the investigator.
- Participants With Normal Renal Function: History or presence of renal 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.
- Participants With Any Renal Impairment (Groups A, B, D, and E): Participant with clinically significant laboratory values in the opinion of the investigator or outside protocol-specified ranges or limits during the screening period or on Day -1.
- Participants With Severe, Moderate, Mild Renal Impairment not on HD (Groups A, D, and E): Current or anticipated need for HD during the study.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07217886
Start Date
October 16 2025
End Date
June 5 2026
Last Update
October 30 2025
Active Locations (4)
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1
Orlando Clicinal Research Center
Orlando, Florida, United States, 32809
2
Global Clinical Professionals (GCP) LLC
St. Petersburg, Florida, United States, 33705
3
Genesis Clinical Research
Tampa, Florida, United States, 33603
4
Alliance for Multispecialty Research (AMR)-Knoxville
Knoxville, Tennessee, United States, 37920