Part A Phase I, Single Ascending Dose Trial of Agomelatine in Healthy Participants
Part A: Phase 1, Single- Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Agomelatine in Healthy Participants.
Seaport Therapeutics Australia Pty LTD
15 participants
Jul 8, 2025
Interventional
Conditions
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.
Eligibility
Inclusion Criteria2
- Male and female participants between the ages of 18 and 55 years, inclusive, at the time of signing the informed consent form.
- 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.
Exclusion Criteria1
- 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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Interventions
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 15 subjects will receive a single 25mg dose of Agomelatine. Participants will be confined to the Clinical Research Unit for supervised dosing. Design: Open-label
Locations(1)
View Full Details on ANZCTR
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ACTRN12625000575437