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

September 29, 2026 updated by: Shionogi

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Altamonte Springs, Florida, United States, 32714
        • Omega Research Orlando, LLC
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 conditions/concurrent medical conditions or laboratory values within 3 months prior to administration of the investigational intervention on Day 1.
  • Body weight ≥ 60 kilograms (kg) for male and ≥ 50 kg for female and body mass index (BMI) within the range 18.5 to 40.0 (inclusive) kg/square meter (m^2) .

Participants With Renal Impairment (Groups A and B):

  • Participants who have mild and moderate renal impairment based on estimated glomerular filtration rate (eGFR) calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula and the participant's body surface area (BSA) at the screening visit (Day -28 to -2).

    • Mild renal impairment: 60 to < 90 milliliters (mL)/minute (min)
    • Moderate renal impairment: 30 to < 60 mL/min

  • A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of the investigational intervention through the follow-up/early termination visit.

Healthy Participants With Normal Renal Function (Group C):

  • Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function based on eGFR, calculated based on the 2021 CKD EPI creatinine formula and the participant's BSA, must be normal (eGFR ≥ 90 mL/min) at the screening visit.
  • Matched to an individual participant with moderate renal impairment (Group B) with respect to age (± 10 years), body weight (± 10 kg), and sex.

Key Exclusion Criteria:

All Participants:

  • History or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.
  • History of GI surgery such as gastrectomy and enterectomy that could lead to clinically significant gastrointestinal dysfunction.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Participants with fluctuating or rapidly deteriorating renal function.
  • Participation in any other clinical study or any other type of medical research involving administration of an investigational intervention (new chemical entity) within 28 days or 5 half-lives of the investigational intervention (if known) prior to dosing, whichever is longer.

Participants With Renal Impairment (Groups A and B):

  • Participant with clinically significant laboratory values in the opinion of the investigator or outside the protocol-defined ranges or limits during the screening period or on Day -1.

Healthy Participants With Normal Renal Function (Group C):

  • History or presence of/significant history of or current renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational intervention; or interfering with the interpretation of data.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Participants with Mild Renal Impairment

Participants with mild renal impairment will receive a single dose of sulthiame in the fasted state on Day 1.
Drug: Sulthiame

Tablet for oral administration

Other Names:
  • S-054502
Experimental: Group B: Participants with Moderate Renal Impairment

Participants with moderate renal impairment will receive a single dose of sulthiame in the fasted state on Day 1.
Drug: Sulthiame

Tablet for oral administration

Other Names:
  • S-054502
Experimental: Group C: Healthy Participants With Normal Renal Function

Healthy participants with normal renal function will receive a single dose of sulthiame in the fasted state on Day 1.
Drug: Sulthiame

Tablet for oral administration

Other Names:
  • S-054502

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of Sulthiame
Time Frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Time to Reach Cmax (Tmax) of Sulthiame
Time Frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Area Under the Plasma Concentration-time Curve Extrapolated From Time 0 to the time of the Last Quantifiable Concentration After Dosing (AUC0-last) of Sulthiame
Time Frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Cmax of Sulthiame Metabolite
Time Frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Tmax of Sulthiame Metabolite
Time Frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
AUC0-last of Sulthiame Metabolite
Time Frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to Day 15
Day 1 up to Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shionogi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 29, 2026

Primary Completion (Estimated)

December 4, 2026

Study Completion (Estimated)

December 11, 2026

Study Registration Dates

First Submitted

September 29, 2026

First Submitted That Met QC Criteria

September 29, 2026

First Posted (Actual)

October 5, 2026

Study Record Updates

Last Update Posted (Actual)

October 5, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2515A4313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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