- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07811063
A Study to Test a Single Dose of a New Tablet Formulation of TRTL-729
2. september 2026 oppdatert av: Tortugas Neuroscience, Inc.
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
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
10
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Auckland, New Zealand
- Clinical Trial Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.
- Able and willing to provide written informed consent and comply with all study procedures and the visit schedule.
- Body Mass Index (BMI) 18.0 to 32.0 kilograms per meter square kg/m^2 and body weight greater than (>)50 kilograms (kg).
- Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), as determined by the investigator.
- QT interval Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.
- Nonsmokers or light smokers (less than [<]10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement.
- 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.
- Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.
Exclusion Criteria:
- Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
- 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.
- 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.
- Active infection or clinically significant recent illness before screening or dosing.
- Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
- Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
- History of malignancy within the past 10 years (except adequately treated nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ).
- Current or recent substance or alcohol use disorder, or positive drug or alcohol screening.
- Current or history of clinically significant psychiatric illness, or suicidal ideation or behavior
- Pregnant, breastfeeding, or planning pregnancy during the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: TRTL-729
Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally.
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Participants will receive TRTL-729 tablets.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to Day 10
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Up to Day 10
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
Tidsramme: Up to Day 10
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Up to Day 10
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Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to Day 10
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Up to Day 10
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Plasma Concentrations of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Maximum Observed Plasma Concentration (Cmax) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Time to Maximum Plasma Concentration (Tmax) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
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From pre-dose on Day 1 through Day 10
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. januar 2027
Studiet fullført (Antatt)
1. januar 2027
Datoer for studieregistrering
Først innsendt
2. september 2026
Først innsendt som oppfylte QC-kriteriene
2. september 2026
Først lagt ut (Faktiske)
9. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 729-CLP-101
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .