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NOT YET RECRUITING
NCT07857837
PHASE1

Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls

Sponsor: Shionogi

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of sulthiame in participants with mild and moderate renal impairment compared to those in healthy participants with normal renal function.

Official title: A Phase 1, Multi-center, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Sulthiame (S-054502) in Participants With Varying Degrees of Renal Impairment and Matched Healthy Control Participants With Normal Renal Function

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09-29

Completion Date

2026-12-11

Last Updated

2026-10-05

Healthy Volunteers

Yes

Interventions

DRUG

Sulthiame

Tablet for oral administration

Locations (2)

Omega Research Orlando, LLC

Altamonte Springs, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States