Study of Sulthiame (S-054502) in Participants With Renal Impairment and Matched Healthy Controls
ConditionRenal Impairment
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShionogi
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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 (m²) .
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sulthiame
DrugTablet for oral administration
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Group A: Participants with Mild Renal ImpairmentExperimental treatment 1 intervention
Group B: Group B: Participants with Moderate Renal ImpairmentExperimental treatment 1 intervention
Group C: Group C: Healthy Participants With Normal Renal FunctionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Observed Plasma Concentration (Cmax) of Sulthiame
Time frame
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)2
Time to Reach Cmax (Tmax) of Sulthiame
Time frame
0 (predose) up to 168 hours postdose (Day 1 up to Day 8)3
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)4
Cmax of Sulthiame Metabolite
Time frame
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)
Time frame
Day 1 up to Day 15 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: