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

Shionogi

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.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Key Inclusion Criteria: All Participants: * Participants who are considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including previous medical conditions/concurrent medical conditions, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiography (ECG) during the screening period and on Day -1. Participants with renal impairment should have no clinically significant changes (based on investigator clinical judgment) in previous medical co…

Interventions

Drug
Sulthiame
Tablet for oral administration

Locations (2)

Omega Research Orlando, LLC
Altamonte Springs, Florida
Floridian Clinical Research
Miami Lakes, Florida

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions