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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05822544
Registration number
NCT05822544
Ethics application status
Date submitted
7/04/2023
Date registered
20/04/2023
Date last updated
13/03/2024
Titles & IDs
Public title
Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity
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Scientific title
A Phase 1/1b Study of Single and Multiple Ascending Doses of TLC 6740 in Healthy Subjects, Including Evaluation of Food Effect and Potential Drug-Drug Interactions, and Preliminary Safety and Efficacy in Subjects With Obesity
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Secondary ID [1]
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6740-CL-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects
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Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TLC-6740 Oral Solution
Other interventions - Placebo
Treatment: Drugs - TLC-6740 Tablet
Treatment: Drugs - Drug Metabolizing Enzyme
Experimental: Oral Solution - Oral solution of TLC-6740
Placebo Comparator: Placebo - Oral dose of TLC-6740 placebo-to-match
Experimental: Tablet - Tablet formulation of TLC-6740
Experimental: Drug Metabolizing Enzyme - Oral dose of omeprazole, voriconazole, or itraconazole
Treatment: Drugs: TLC-6740 Oral Solution
Oral solution of TLC-6740
Other interventions: Placebo
Placebo-to-match
Treatment: Drugs: TLC-6740 Tablet
Tablet formulation of TLC-6740
Treatment: Drugs: Drug Metabolizing Enzyme
Oral dose of omeprazole, voriconazole, or itraconazole
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of TLC-6740 treatment-emergent adverse events
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Assessment method [1]
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Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.
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Timepoint [1]
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Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Part F) of the study
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Primary outcome [2]
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PK of TLC-6740 AUC
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Assessment method [2]
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Area under the concentration-time curve
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Timepoint [2]
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Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Part F) of the study
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Primary outcome [3]
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PK of TLC-6740 Cmax
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Assessment method [3]
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Maximum plasma concentration
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Timepoint [3]
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Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Part F) of the study
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Primary outcome [4]
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PK of TLC-6740 tmax
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Assessment method [4]
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Time to reach Cmax
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Timepoint [4]
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Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Part F) of the study
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Primary outcome [5]
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PK of TLC-6740 t1/2
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Assessment method [5]
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Half-life
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Timepoint [5]
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Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Part F) of the study
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Primary outcome [6]
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PK of TLC-6740 CL/F
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Assessment method [6]
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Apparent clearance, calculated as dose/AUC0-inf
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Timepoint [6]
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Through study completion: up to Day 15 (Parts A, C); Day 24 (Parts B, C); Day 22 (Part D); Day 49 (Part E); Day 87 (Part F) of the study
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Eligibility
Key inclusion criteria
- Non-smoking, healthy male or female subject between 18 and 55 years of age, inclusive
(Parts A-E); male or female subject between 18 and 70 years of age, inclusive (Part F)
- Body mass index (BMI) from 19 to 35 kg/m2, inclusive (Parts A-E); BMI = 30 kg/m2 (Part
F)
- Estimated glomerular filtration rate (eGFR) = 80 mL/min (Parts A-E); eGFR = 60 mL/min
(Part F)
- Normal liver biochemistry tests (Parts A-E)
- Screening laboratory evaluations (hematology, chemistry, and urinalysis) must fall
within the normal range of the local laboratory's reference ranges unless the results
have been determined by the investigator to have no clinical significance (Parts A-E)
- Subject must have either a normal 12-lead electrocardiogram (ECG) or one with
abnormalities that are considered clinically insignificant by the investigator
- Females of childbearing potential must have a negative pregnancy test at Screening and
clinic admission
- Male subjects and female subjects of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception
- Must, in the opinion of the investigator, be in good health based upon medical history
and physical examination, including vital signs
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Pregnant or lactating subjects
- HbA1c > 9.5% (Part F)
- Subjects who have any serious or active medical or psychiatric illness (including
depression) that, in the opinion of the investigator, would interfere with the
subject's treatment, assessment, or compliance with the protocol
- Subjects who have received any investigational compound within 30 days or 5
half-lives, whichever is longer, prior to study drug dosing
- Current alcohol abuse that is judged by the investigator to potentially interfere with
the subject's compliance or safety
- Current substance abuse that is judged by the investigator to potentially interfere
with the subject's compliance or safety
- A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B
(HBV) surface antigen, or hepatitis C (HCV) antibody
- Medical history of drug sensitivity or drug allergy (such as anaphylaxis or
hepatoxicity)
- Presence or history of cardiovascular disease, including significant cardiovascular
disease (including a history of myocardial infarction based on ECG and/or clinical
history), history of cardiac conduction abnormalities (including any history of
ventricular tachycardia), congestive heart failure, cardiomyopathy with left
ventricular ejection fraction < 40%, a family history of Long QT Syndrome, or
unexplained death in an otherwise healthy individual between the ages of 1 and 30
years
- Syncope, palpitations, or unexplained dizziness
- Implanted defibrillator or pacemaker
- Medical history of liver disease, including but not limited to alcoholic liver
disease, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing
cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease,
clinically significant iron overload, or alpha-1-antitrypsin deficiency)
- Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid
hypersecretory conditions
- History of medical or surgical treatment that permanently alters intestinal absorption
(e.g., gastric or intestinal surgery)
- Subjects who have received vaccination for COVID-19 within 14 days of Admission
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2025
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Actual
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Sample size
Target
236
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
OrsoBio, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The phase 1 portion of the study is designed to evaluate the safety, tolerability,
pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and
multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed
to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05822544
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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OrsoBio Study Director
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Address
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OrsoBio, Inc
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ryan Huss, MD
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Address
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Country
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Phone
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650-382-2225
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05822544
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