Menu
Recruiting NCT07433179

A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SEP-479, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 21 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SEP-479 in Healthy Adult Participants

Overview

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-479 in healthy adult participants.

Interventions

  • Drug SEP-479
    Oral, capsule
  • Other Placebo
    Oral, capsule

Primary outcome measures

  • Frequency of treatment emergent adverse events [Time frame: From enrollment to end of follow up visit, up to approximately 2 months]
Secondary outcome measures (5)
  • Plasma PK of SEP-479 after single and multiple doses [Time frame: From enrollment to end of treatment period, up to approximately 14 days]
  • Plasma PK of SEP-479 after single and multiple doses [Time frame: From enrollment to end of treatment period, up to approximately 14 days]
  • Plasma PK of SEP-479 under fed and fasted conditions [Time frame: From enrollment to end of treatment period, up to approximately 14 days]
  • Plasma PK of SEP-479 after single and multiple doses [Time frame: From enrollment to end of treatment period, up to approximately 14 days]
  • Plasma PK of SEP-479 under fed and fasted conditions [Time frame: From enrollment to end of treatment period, up to approximately 14 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Nucleus Network — Melbourne

Identifiers

NCT: NCT07433179 · SEP-479-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗