The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Nucleus Network Melbourne
Melbourne, Australia
Frequency of treatment emergent adverse events
Time frame: From enrollment to end of follow up visit, up to approximately 2 months
Plasma PK of SEP-631 after single and multiple doses
Maximum Plasma Concentration (Cmax) of SEP-631
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Maximum Plasma Concentration (Cmax) of SEP-631
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Elimination half=life (T 1/2) of SEP-631
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 after single and multiple doses
Area Under the Concentration-time Curve (AUC) of SEP-631
Time frame: From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
Area Under the Concentration-time Curve (AUC) of SEP-631
Time frame: From enrollment to end of treatment period, up to approximately 14 days
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