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RECRUITING
NCT07217886
PHASE1

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

Sponsor: Shionogi

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Multicenter, Nonrandomized, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of S-892216-PO in Participants With Varying Degrees of Renal Impairment and Matched Control Participants With Normal Renal Function

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-10-16

Completion Date

2026-06-05

Last Updated

2025-10-30

Healthy Volunteers

Yes

Interventions

DRUG

S-892216-PO

S-892216-PO tablet will be administered orally.

Locations (4)

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