Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-479 in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose | Experimental |
| |
| Multiple Ascending Dose | Experimental |
| |
| Food Effect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEP-479 | Drug | Oral, capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment emergent adverse events | From enrollment to end of follow up visit, up to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK of SEP-479 after single and multiple doses | Maximum Plasma Concentration (Cmax) of SEP-479 | From enrollment to end of treatment period, up to approximately 14 days |
| Plasma PK of SEP-479 after single and multiple doses |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Melbourne | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Oral, capsule |
|
Elimination half-life (T 1/2) of SEP-479
| From enrollment to end of treatment period, up to approximately 14 days |
| Plasma PK of SEP-479 under fed and fasted conditions | Maximum Plasma Concentration (Cmax) of SEP-479 | From enrollment to end of treatment period, up to approximately 14 days |
| Plasma PK of SEP-479 after single and multiple doses | Area Under the Concentration-time Curve (AUC) of SEP-479 | From enrollment to end of treatment period, up to approximately 14 days |
| Plasma PK of SEP-479 under fed and fasted conditions | Area Under the Concentration-time Curve (AUC) of SEP-479 | From enrollment to end of treatment period, up to approximately 14 days |