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 C is a food-effect crossover study designed to evaluate how a standard meal influences the pharmacokinetics of SPT-320 and Agomelatine.
Interventions
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 Per
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
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