None listed
Conditions
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.
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
Sponsors
Seaport Therapeutics Australia Pty LTD
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed