A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls

Shionogi

Status and phase: Enrolling; Phase 1

Conditions: Renal Impairment

Treatments: Drug: S-892216-PO

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT07217886

2420T1614

Details and patient eligibility

About

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 renal impairment requiring hemodialysis (HD), and in participants with normal renal function.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 5 patient groups

Group A (Severe Renal Impairment)

Experimental group

Description:

Participants with severe renal impairment not on HD will receive S-892216-PO.

Treatment:

Drug: S-892216-PO

Group B (Renal Impairment)

Experimental group

Description:

Participants with renal impairment requiring HD will receive S-892216-PO.

Treatment:

Drug: S-892216-PO

Group C (Normal Renal Function)

Experimental group

Description:

Participants with normal renal function will receive S-892216-PO.

Treatment:

Drug: S-892216-PO

Group D (Moderate Renal Impairment)

Experimental group

Description:

Participants with moderate impairment will receive S-892216-PO.

Treatment:

Drug: S-892216-PO

Group D (Mild Renal Impairment)

Experimental group

Description:

Participants with mild impairment will receive S-892216-PO.

Treatment:

Drug: S-892216-PO