A Study of S-892216-PO in Participants With Renal Impairm... | NCT07217886

NCT07217886

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Biomedical Advanced Research and Development Authority	FED

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A (Severe Renal Impairment)	Experimental	Participants with severe renal impairment not on HD will receive S-892216-PO.	Drug: S-892216-PO
Group B (Renal Impairment)	Experimental	Participants with renal impairment requiring HD will receive S-892216-PO.	Drug: S-892216-PO
Group C (Normal Renal Function)	Experimental	Participants with normal renal function will receive S-892216-PO.	Drug: S-892216-PO
Group D (Moderate Renal Impairment)	Experimental	Participants with moderate impairment will receive S-892216-PO.	Drug: S-892216-PO
Group D (Mild Renal Impairment)	Experimental	Participants with mild impairment will receive S-892216-PO.	Drug: S-892216-PO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-892216-PO	Drug	S-892216-PO tablet will be administered orally.	Group A (Severe Renal Impairment) Group B (Renal Impairment) Group C (Normal Renal Function)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of S-892216		Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216		Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only
Group B Only: Cumulative Amount of the Drug Recovered in Dialysate (AHD) of S-892216		Day 1 (up to 6 hours postdose)
Group B Only: Area Under the Dialysate Concentration in the Arterial Sides of Port-time Curve During Hemodialysis (AUChd) of S-892216		Day 1 (up to 6 hours postdose)

Measure	Description	Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		Day 1 through Day 39

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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 Criteria:

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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications