A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
← catalyst calendarSponsored by Shionogi (industry) · 4507.T — their whole pipeline →. With Biomedical Advanced Research and Development Authority.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
24actual
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-16 | actual | When the study began enrolling |
| Primary completion | 2026-02-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-13 | actual | The whole study's end, after follow-up |
| First posted | 2025-10-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Renal Impairment
Intervention
- Drug: S-892216-PO
Primary outcomes
what the primary-completion date above is the date OFMaximum Plasma Concentration (Cmax) of S-892216
measured 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
measured 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
measured 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
measured Day 1 (up to 6 hours postdose)
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