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
NCT ID NCT07811063
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Trial Site
Auckland, New Zealand
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