Trial Review

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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
Scientific title
Part A: Phase 1, Single- Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Agomelatine in Healthy Participants.
Secondary ID [1] 314144 0
SPT-320-2024-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336987 0
Condition category
Condition code
Mental Health 333448 333448 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 330733 0
Treatment: Drugs
Comparator / control treatment
There is no comparator or control treatment in Part A.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341028 0
To evaluate the pharmacokinetics (PK) of agomelatine key exposure parameters including Cmax, tmax AUC.
Timepoint [1] 341028 0
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
Secondary outcome [1] 446071 0
Safety and tolerability - treatment-emergent adverse events [TEAs]
Timepoint [1] 446071 0
Safety and tolerability will be assessed daily during the inpatient period and at the Day 7 safety follow-up visit.

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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
16/07/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318654 0
Commercial sector/Industry
Name [1] 318654 0
Seaport Therapeutics Australia Pty LTD
Country [1] 318654 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Seaport Therapeutics Australia Pty LTD
Address
Country
Australia
Secondary sponsor category [1] 321092 0
None
Name [1] 321092 0
Address [1] 321092 0
Country [1] 321092 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317268 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 317268 0
Ethics committee country [1] 317268 0
Australia
Date submitted for ethics approval [1] 317268 0
09/04/2025
Approval date [1] 317268 0
Ethics approval number [1] 317268 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140510 0
Dr Sepehr Shakib
Address 140510 0
CMAX Clinical Research Level 5, 18a North Terrace, Adelaide SA 5000, AUSTRALIA
Country 140510 0
Australia
Phone 140510 0
+61 0411 100 278
Fax 140510 0
Email 140510 0
[email protected]
Contact person for public queries
Name 140511 0
Sergey Yagoda
Address 140511 0
Seaport Medical, 101 Seaport Blvd, Floor 12, Boston MA 02210
Country 140511 0
United States of America
Phone 140511 0
+16178074062
Fax 140511 0
Email 140511 0
[email protected]
Contact person for scientific queries
Name 140512 0
Sergey Yagoda
Address 140512 0
Seaport Medical, 101 Seaport Blvd, Floor 12, Boston MA 02210
Country 140512 0
United States of America
Phone 140512 0
+16178074062
Fax 140512 0
Email 140512 0
[email protected]

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.