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A Study to Test a Single Dose of a New Tablet Formulation of TRTL-729

2. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Auckland, New Zealand
        • Clinical Trial Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.
  2. Able and willing to provide written informed consent and comply with all study procedures and the visit schedule.
  3. Body Mass Index (BMI) 18.0 to 32.0 kilograms per meter square kg/m^2 and body weight greater than (>)50 kilograms (kg).
  4. Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), as determined by the investigator.
  5. QT interval Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.
  6. 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.
  7. 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.
  8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.

Exclusion Criteria:

  1. Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
  2. 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.
  3. 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.
  4. Active infection or clinically significant recent illness before screening or dosing.
  5. Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
  6. Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
  7. History of malignancy within the past 10 years (except adequately treated nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ).
  8. Current or recent substance or alcohol use disorder, or positive drug or alcohol screening.
  9. Current or history of clinically significant psychiatric illness, or suicidal ideation or behavior
  10. Pregnant, breastfeeding, or planning pregnancy during the study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TRTL-729
Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally.
Participants will receive TRTL-729 tablets.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to Day 10
Up to Day 10
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
Tidsramme: Up to Day 10
Up to Day 10
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to Day 10
Up to Day 10

Sekundære resultatmål

Resultatmål
Tidsramme
Plasma Concentrations of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
Maximum Observed Plasma Concentration (Cmax) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
Time to Maximum Plasma Concentration (Tmax) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10
Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729
Tidsramme: From pre-dose on Day 1 through Day 10
From pre-dose on Day 1 through Day 10

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. januar 2027

Datoer for studieregistrering

Først indsendt

2. september 2026

Først indsendt, der opfyldte QC-kriterier

2. september 2026

Først opslået (Faktiske)

9. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 729-CLP-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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