Renal ImpairmentPhase 1NCT07857837
Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
A Phase 1 study testing Sulthiame in people with Renal Impairment, run by Shionogi at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Sulthiame
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2026to 11 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
United States2 sites
Omega Research Orlando, LLC
Altamonte Springs, Florida, 32714
Floridian Clinical Research
Miami Lakes, Florida, 33016
About this study
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
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.
- Conditions
- Renal Impairment
- Being tested
- Sulthiame
- Keywords
- Sulthiame, S-054502, Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulthiameDrug
Also called S-054502
Tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group A: Participants with Mild Renal Impairment | Experimental | Participants with mild renal impairment will receive a single dose of sulthiame in the fasted state on Day 1. Receives: Drug: Sulthiame |
| Group B: Participants with Moderate Renal Impairment | Experimental | Participants with moderate renal impairment will receive a single dose of sulthiame in the fasted state on Day 1. Receives: Drug: Sulthiame |
| Group C: Healthy Participants With Normal Renal Function | Experimental | Healthy participants with normal renal function will receive a single dose of sulthiame in the fasted state on Day 1. Receives: Drug: Sulthiame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Sulthiame
Measured: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Time to Reach Cmax (Tmax) of Sulthiame
Measured: 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
Measured: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Cmax of Sulthiame Metabolite
Measured: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Tmax of Sulthiame Metabolite
Measured: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
AUC0-last of Sulthiame Metabolite
Measured: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
Secondary outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start29 Sep 2026 (estimated)
- Primary completion4 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857837
- Sponsor's protocol ID
- 2515A4313
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07857837
- Acronym / sponsor ID
- 2515A4313
- Conditions
- Renal Impairment
- Keywords
- Sulthiame, S-054502, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Participants with Mild Renal Impairment | Experimental | Drug: SulthiameParticipants with mild renal impairment will receive a single dose of sulthiame in the fasted state on Day 1. |
| Group B: Participants with Moderate Renal Impairment | Experimental | Drug: SulthiameParticipants with moderate renal impairment will receive a single dose of sulthiame in the fasted state on Day 1. |
| Group C: Healthy Participants With Normal Renal Function | Experimental | Drug: SulthiameHealthy participants with normal renal function will receive a single dose of sulthiame in the fasted state on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 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).
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulthiameAlso: S-054502Tablet for oral administration | Drug | Group A: Participants with Mild Renal Impairment, Group B: Participants with Moderate Renal Impairment, Group C: Healthy Participants With Normal Renal Function |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Sulthiame
Time frame: 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)
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)
Cmax of Sulthiame Metabolite
Time frame: 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)
AUC0-last of Sulthiame Metabolite
Time frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)
1 secondary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shionogi Clinical Trials Administrator Clinical Support Help Line contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sulthiame in people with Renal Impairment, run by Shionogi at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shionogi Clinical Trials Administrator Clinical Support Help Line (1-800-849-9707, Shionogiclintrials-admin@shionogi.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of Sulthiame (time frame: 0 (predose) up to 168 hours postdose (Day 1 up to Day 8)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.