Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001137482
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/05/2025
Date registered
Help: Date registered
17/10/2025
Date last updated
Help: Date last updated
4/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
17/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Part C: A Phase 1 trial to assess the effect of food on SPT-320 in Healthy Participants.
Scientific title
Part C: Phase 1, Double-Blind, Placebo-Controlled, 4-Part, Single- and Multiple-Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of SPT-320 in Healthy Participants
Additional trial identifiers [1] 314406 0
SPT-320-2024-101
Universal Trial Number (UTN)
Trial acronym
Related trial records
This study is linked to the study noted in ACTRN12625000575437

Health condition
Health condition(s) studied:
Anxiety 337415 0
Condition category
Condition code
Mental Health 333794 333794 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study evaluates the effect of food on the pharmacokinetics of SPT-320 and Agomelatine in healthy participants.
Part C – Food Effect Crossover Study
Intervention: Single oral dose of SPT-320 (capsule) or Agomelatine (tablet) per period (3 total periods) under fasted or fed conditions separated by wash-out periods (5-7 days)
Dose levels: : Participants will be randomized to receive SPT-320 fed or fasted in Period 1 (dose level to be determined), SPT-320 fed or fasted whichever is opposite Period 1 in Period 2, and Agomelatine (single oral 25 mg dose) either fed or fasted in Period 3 to match Period 1. As SPT- 320 human exposure is unknown, the dose will be a minimum dose of 1 mg and a maximum dose of 400 mg. The safety review committee will review ongoing data to determine dose decisions. Participants will be confined to the Clinical Research Unit for supervised dosing and there will be a 5-7- day wash-out period between doses. The standard meal will consist of approximately 50% carbohydrate, 35% fat and 15% protein.
Design: Open-label, randomized, 3-period, 2-sequence crossover
Intervention code [1] 331011 0
Treatment: Drugs
Description of the comparator or control
Agomelatine - single oral 25mg dose (tablet). Participants will be confined to the Clinical Research Unit for supervised dosing.
Control group
Active

Outcomes
Primary outcome [1] 341372 0
To evaluate the effect of food and the pharmacokinetics (PK) of SPT-320 relative to agomelatine key exposure parameters including Cmax, tmax, AUC..
Timepoint [1] 341372 0
Blood samples for pharmacokinetic analysis will be collected at the following timepoints relative to dose administration: pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 36,48,and 72 hours post-dose during the inpatient periods 1, 2 and 3.
Primary outcome [2] 342639 0
To evaluate the effect of food on the pharmacokinetics (PK) of SPT-320 relative to Agomelatine with key exposure parameters including Cmax, tmax, AUC.
Timepoint [2] 342639 0
Blood samples for pharmacokinetic analysis will be collected at the following timepoints relative to dose administration: pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 36, 48,and 72 hours post-dose during the inpatient periods 1, 2 and 3.
Secondary outcome [1] 447341 0
Safety and tolerability - treatment-emergent adverse events [TEAs].
Timepoint [1] 447341 0
Safety and tolerability will be assessed daily during the inpatient periods 1, 2 and 3 and at the Day 7 safety follow-up visit following.

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
Healthy volunteers
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
Randomised controlled 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
Completed
Date of first participant enrolment
Anticipated
30/11/2025
Actual
19/11/2025
Date of last participant enrolment
Anticipated
30/06/2026
Actual
21/01/2026
Date of last data collection
Anticipated
16/07/2026
Actual
12/02/2026
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318927 0
Commercial sector/Industry
Name [1] 318927 0
Seaport Therapeutics Australia Pty lTD
Country [1] 318927 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Seaport Therapeutics Australia Pty lTD
Address
Country
Australia
Secondary sponsor category [1] 321396 0
None
Name [1] 321396 0
Address [1] 321396 0
Country [1] 321396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317540 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 317540 0
Ethics committee country [1] 317540 0
Australia
Date submitted for ethics approval [1] 317540 0
09/04/2025
Approval date [1] 317540 0
15/05/2025
Ethics approval number [1] 317540 0
2025-04-565

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

Contacts
Principal investigator
Name 141374 0
Dr Sepehr Shakib
Address 141374 0
CMAX Clinical Research Level 5, 18a North Terrace, Adelaide SA 5000, AUSTRALIA
Country 141374 0
Australia
Phone 141374 0
+61 0411 100 278
Fax 141374 0
Email 141374 0
[email protected]
Contact person for public queries
Name 141375 0
Sergey Yagoda
Address 141375 0
Seaport Therapeutics, 101 Seaport Blvd, Floor 12, Boston MA 02210
Country 141375 0
United States of America
Phone 141375 0
+16178074062
Fax 141375 0
Email 141375 0
[email protected]
Contact person for scientific queries
Name 141376 0
Sergey Yagoda
Address 141376 0
Seaport Therapeutics, 101 Seaport Blvd, Floor 12, Boston MA 02210
Country 141376 0
United States of America
Phone 141376 0
+16178074062
Fax 141376 0
Email 141376 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.