NCT07433179RecruitingPhase 1
A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SEP-479 in Healthy Adult Participants
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Septerna, Inc.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Frequency of treatment emergent adverse events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-479 in healthy adult participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who are able and willing to provide informed consent
- •Aged 21 to 60 years at the time of consent
- •Have a BMI within the range 18.0 to 32.0 kg/m2
- •In general good health
Exclusion Criteria
- •Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
- •Have clinically significant abnormalities on clinical laboratory results.
- •Participation in other clinical trials recently/currently
Arms & Interventions
Single Ascending Dose
Experimental
Intervention: SEP-479 (Drug)
Single Ascending Dose
Experimental
Intervention: Placebo (Other)
Multiple Ascending Dose
Experimental
Intervention: SEP-479 (Drug)
Multiple Ascending Dose
Experimental
Intervention: Placebo (Other)
Food Effect
Experimental
Intervention: SEP-479 (Drug)
Outcomes
Primary Outcomes
Frequency of treatment emergent adverse events
Time Frame: From enrollment to end of follow up visit, up to approximately 2 months
Secondary Outcomes
- Plasma PK of SEP-479 after single and multiple doses(From enrollment to end of treatment period, up to approximately 14 days)
- Plasma PK of SEP-479 under fed and fasted conditions(From enrollment to end of treatment period, up to approximately 14 days)
Investigators
Study Sites (1)
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