[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655269":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":52,"overallOfficials":11,"centralContacts":11,"locations":57,"responsibleParty":69,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Tortugas Neuroscience, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)",null,"Up to Day 10",{"measure":14,"description":11,"timeFrame":12},"Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)",{"measure":16,"description":11,"timeFrame":12},"Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)",[18,21,23,25,27,29,31,33,35,37],{"measure":19,"description":11,"timeFrame":20},"Plasma Concentrations of TRTL-729","From pre-dose on Day 1 through Day 10",{"measure":22,"description":11,"timeFrame":20},"Maximum Observed Plasma Concentration (Cmax) of TRTL-729",{"measure":24,"description":11,"timeFrame":20},"Time to Maximum Plasma Concentration (Tmax) of TRTL-729",{"measure":26,"description":11,"timeFrame":20},"AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729",{"measure":28,"description":11,"timeFrame":20},"Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729",{"measure":30,"description":11,"timeFrame":20},"AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729",{"measure":32,"description":11,"timeFrame":20},"AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729",{"measure":34,"description":11,"timeFrame":20},"Apparent Terminal Elimination Half-Life (t1\u002F2) of TRTL-729",{"measure":36,"description":11,"timeFrame":20},"Apparent Total Plasma Clearance After Oral Administration (CL\u002FF) of TRTL-729",{"measure":38,"description":11,"timeFrame":20},"Apparent Volume of Distribution During Terminal Phase (Vz\u002FF) of TRTL-729",{"allocation":40,"interventionModel":41,"interventionModelDescription":11,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":44,"maskingDescription":11,"whoMasked":11},"NONE",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"TRTL-729","EXPERIMENTAL","Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally.",[51],"Drug: TRTL-729",[53],{"type":54,"name":47,"description":55,"armGroupLabels":56,"otherNames":11},"DRUG","Participants will receive TRTL-729 tablets.",[47],[58],{"facility":59,"status":11,"city":60,"state":11,"zip":11,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":11},"Clinical Trial Site","Auckland","New Zealand","NZ",{"type":64,"coordinates":65},"Point",[66,67],174.76349,-36.84853,{"lat":67,"lon":66},{"type":70,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100655269","phase-1-a-study-to-test-a-single-dose-of-a-new-tablet-formulation-of-trtl-729-100655269",false,"NCT07811063","A Study to Test a Single Dose of a New Tablet Formulation of TRTL-729","An Open-Label Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Dose of a New Tablet Formulation of TRTL-729 in Healthy Adults","Inclusion Criteria:\n\n1. Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.\n2. Able and willing to provide written informed consent and comply with all study procedures and the visit schedule.\n3. Body Mass Index (BMI) 18.0 to 32.0 kilograms per meter square kg\u002Fm\\^2 and body weight greater than (\\>)50 kilograms (kg).\n4. Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), as determined by the investigator.\n5. QT interval Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.\n6. Nonsmokers or light smokers (less than \\[\\\u003C\\]10 cigarettes\u002Fweek or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement.\n7. Females must be of nonchildbearing potential or, if of childbearing potential, must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period.\n8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.\n\nExclusion Criteria:\n\n1. Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.\n2. History of seizures, epilepsy, significant head injury associated with loss of consciousness, family history of seizures or epilepsy, or other conditions or medications that increase seizure risk.\n3. Clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, clinically significant ECG abnormalities, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.\n4. Active infection or clinically significant recent illness before screening or dosing.\n5. Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.\n6. Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.\n7. History of malignancy within the past 10 years (except adequately treated nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ).\n8. Current or recent substance or alcohol use disorder, or positive drug or alcohol screening.\n9. Current or history of clinically significant psychiatric illness, or suicidal ideation or behavior\n10. Pregnant, breastfeeding, or planning pregnancy during the study.",true,"ALL","18 Years","55 Years",{"count":83,"type":84},10,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.",[90],"Healthy Volunteers",[47],"NOT_YET_RECRUITING","2026-09-29",{"date":95,"type":96},"2026-10-05","ACTUAL",{"date":98,"type":84},"2026-09",{"date":100,"type":84},"2027-01",{"name":5,"class":6},1]