Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.
Interventions
DRUGSEP-631
Oral, tablet
OTHERPlacebo
Oral, tablet
Sponsors
Septerna, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects who are able and willing to provide informed consent 2. Aged 18 to 60 years at the time of consent 3. Have a BMI within the range 18.5 to 32.0 kg/m2 4. In general good health
Exclusion criteria
1. Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. 2. Have a history of any severe allergic reaction or anaphylaxis 3. Have clinically significant abnormalities on clinical laboratory results. 4. Participation in other clinical trials recently/currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of treatment emergent adverse events | From enrollment to end of follow up visit, up to approximately 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PK of SEP-631 after single and multiple doses | From enrollment to end of treatment period, up to approximately 14 days | Maximum Plasma Concentration (Cmax) of SEP-631 |
| Plasma PK of SEP-631 under fed and fasted conditions | From enrollment to end of treatment period, up to approximately 14 days | Maximum Plasma Concentration (Cmax) of SEP-631 |
Countries
Australia
Outcome results
None listed