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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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