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 B evaluates single ascending doses of SPT-320 compared with placebo. Part D studies multiple ascending doses of SPT-320 given once daily for 7 days, compared with placebo.
Interventions
This study evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary pharmacodynamics of SPT-320 and agomelatine following single dose in healthy adult participants.
Part B – Single Ascending Dose (SAD)
Intervention: Single oral dose of SPT-320 (oprodrug of agomelatine) or placebo
Dose levels: As SPT-320 human exposure is unknown, the dose range and number of doses to be assessed are TBD , with a minimum dose of 1 mg and a maximum dose of 400 mg. The safety review committee will
This study evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary pharmacodynamics of SPT-320 and agomelatine following single dose in healthy adult participants. Part B – Single Ascending Dose (SAD) Intervention: Single oral dose of SPT-320 (oprodrug of agomelatine) or placebo Dose levels: As SPT-320 human exposure is unknown, the dose range and number of doses to be assessed are TBD , with 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. Design: Randomized, double-blind, placebo-controlled Part D – Multiple Ascending Dose (MAD) Intervention: Multiple oral doses of SPT-320 or placebo once daily for 7 days Dose levels: As SPT-320 human exposure is unknown, the dose range and number of doses to be assessed are TBD, with 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. Design: Randomized, double-blind, placebo-controlled
Sponsors
Seaport Therapeutics Australia Pty Ltd
Study design
Allocation
Randomised controlled 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