protocolSection identificationModule nctId: NCT06277492, orgStudyIdInfo id: GN-001, briefTitle: A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-08-09, completionDateStruct date: 2025-11-08, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: GEN İlaç ve Sağlık Ürünleri A.Ş., class: INDUSTRY, collaborators name: Sulfateq B.V., descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled, single-center study is to evaluate the safety, tolerability, pharmacokinetics of single and multiple oral doses of SUL-238 in healthy subjects (aged ≥40 years)., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: Single ascending doses SUL-238, interventions name: Single dose Placebo, interventions name: Single dose SUL-238, interventions name: Multiple ascending doses SUL-238, interventions name: Multiple doses Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by NCI-CTCAE criteria, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by Clinical Laboratory Measurements According to Established Clinical Normal Ranges, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by ECG, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by physical examination and vital signs, primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events as Measured by central nervous system (CNS) and autonomic nervous system (ANS) examination., secondaryOutcomes measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after a single ascending dose (Part 1 and Part 2)., secondaryOutcomes measure: PK parameter: Maximum drug concentration in plasma (Cmax) of SUL-238 after multiple ascending doses (Part 3)., secondaryOutcomes measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after single ascending dose (Part 1 and Part 2)., secondaryOutcomes measure: PK parameter: Area under the concentration-time curve in plasma (AUC) of SUL-238 after multiple ascending doses (Part 3)., secondaryOutcomes measure: Renal clearance and percentage of drug excreted in urine after single and multiple ascending doses of SUL-238., secondaryOutcomes measure: Percentage of drug excreted in feces after multiple ascending doses of SUL-238., secondaryOutcomes measure: The cerebrospinal fluid (CSF) levels of SUL-238, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University IKUM Center, status: RECRUITING, city: Kayseri, zip: 38030, country: Turkey, contacts name: Zafer Sezer, MD, role: CONTACT, phone: +903522076666, phoneExt: 24405, email: drzafersezer@gmail.com, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False