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Trial registered on ANZCTR
Registration number
ACTRN12625000575437p
Ethics application status
Submitted, not yet approved
Date submitted
17/04/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Part A Phase I, Single Ascending Dose Trial of Agomelatine in Healthy Participants
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Scientific title
Part A: Phase 1, Single- Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Agomelatine in Healthy Participants.
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Secondary ID [1]
314144
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SPT-320-2024-101
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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:
Anxiety
336987
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Condition category
Condition code
Mental Health
333448
333448
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary pharmacodynamics of agomelatine following a single oral dose in healthy adult participants.
Part A - Agomelatine
Intervention: Single oral dose of Agomelatine
Dose: One cohort of up to 10 subjects will receive a single 25mg dose of Agomelatine. Participants will be confined to the Clinical Research Unit for supervised dosing.
Design: Open-label
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Intervention code [1]
330733
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Treatment: Drugs
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Comparator / control treatment
There is no comparator or control treatment in Part A.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To evaluate the pharmacokinetics (PK) of agomelatine key exposure parameters including Cmax, tmax AUC.
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Assessment method [1]
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Measure the blood concentrations of agomelatine after a single dose.
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Timepoint [1]
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Blood samples will be collected at the following timepoints relative to dose administration: pre-dose and at .25, .5, .75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, and 24 hours post-dose
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Secondary outcome [1]
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Safety and tolerability - treatment-emergent adverse events [TEAs]
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Assessment method [1]
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Assessments will include adverse events (assessed continuously as observed), vital signs (blood pressure and pulse rate assessed using digital sphygmomanometer, respiratory rate assessed by counting and tympanic body temperature assessed using digital thermometer), laboratory tests (blood and urine samples), physical examinations as assessed by qualified research staff, ECGs (assessed by 12-lead ECG machine), and the Columbia Suicide Severity Rating Scale conducted by qualified research staff.
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Timepoint [1]
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Safety and tolerability will be assessed daily during the inpatient period and at the Day 7 safety follow-up visit.
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Eligibility
Key inclusion criteria
1. Male and female participants between the ages of 18 and 55 years, inclusive, at the time of signing the informed consent form.
2. Healthy participants, as determined by the absence of clinically relevant abnormalities in medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory tests, as evaluated by the investigator.
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Minimum age
18
Years
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Maximum age
55
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
1. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
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Who is / are masked / blinded?
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Intervention assignment
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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
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/07/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2026
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Actual
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Date of last data collection
Anticipated
16/07/2026
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
318654
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Commercial sector/Industry
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Name [1]
318654
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Seaport Therapeutics Australia Pty LTD
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Address [1]
318654
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Seaport Therapeutics Australia Pty LTD
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
321092
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Country [1]
321092
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317268
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Bellberry Human Research Ethics Committee H
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Ethics committee address [1]
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https://bellberry.com.au/
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Ethics committee country [1]
317268
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Australia
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Date submitted for ethics approval [1]
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09/04/2025
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Approval date [1]
317268
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Ethics approval number [1]
317268
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Summary
Brief summary
This is a Phase 1, four-part clinical trial in healthy adult participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPT-320, an investigational oral prodrug of agomelatine. Part A involves a single dose of agomelatine to establish baseline pharmacokinetic data.
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Trial website
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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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Dr Sepehr Shakib
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Address
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CMAX Clinical Research Level 5, 18a North Terrace, Adelaide SA 5000, AUSTRALIA
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Country
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Australia
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Phone
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+61 0411 100 278
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sergey Yagoda
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Address
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Seaport Medical, 101 Seaport Blvd, Floor 12, Boston MA 02210
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Country
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United States of America
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Phone
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+16178074062
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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
Name
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Sergey Yagoda
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Address
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Seaport Medical, 101 Seaport Blvd, Floor 12, Boston MA 02210
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Country
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United States of America
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Phone
140512
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+16178074062
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Fax
140512
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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