CompletedPhase 1

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

United States24 participantsStarted 2025-10-16

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 neur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Plasma Concentration (Cmax) of S-892216

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Day 1 (up to 6 hours postdose)

Trial details

NCT IDNCT07217886

SponsorShionogi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-13

View on ClinicalTrials.gov More Renal Impairment trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum Plasma Concentration (Cmax) of S-892216

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Day 1 (up to 6 hours postdose)