A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
NCT ID: NCT07217886
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2025-10-16
2026-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A (Severe Renal Impairment)
Participants with severe renal impairment not on HD will receive S-892216-PO.
S-892216-PO
S-892216-PO tablet will be administered orally.
Group B (Renal Impairment)
Participants with renal impairment requiring HD will receive S-892216-PO.
S-892216-PO
S-892216-PO tablet will be administered orally.
Group C (Normal Renal Function)
Participants with normal renal function will receive S-892216-PO.
S-892216-PO
S-892216-PO tablet will be administered orally.
Group D (Moderate Renal Impairment)
Participants with moderate impairment will receive S-892216-PO.
S-892216-PO
S-892216-PO tablet will be administered orally.
Group D (Mild Renal Impairment)
Participants with mild impairment will receive S-892216-PO.
S-892216-PO
S-892216-PO tablet will be administered orally.
Interventions
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S-892216-PO
S-892216-PO tablet will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Shionogi
INDUSTRY
Responsible Party
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Locations
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Orlando Clicinal Research Center
Orlando, Florida, United States
Global Clinical Professionals (GCP) LLC
St. Petersburg, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Alliance for Multispecialty Research (AMR)-Knoxville
Knoxville, Tennessee, United States
Countries
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Central Contacts
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: CONTACT
Other Identifiers
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2420T1614
Identifier Type: -
Identifier Source: org_study_id
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