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Completed

NCT Number: NCT07069036

A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Melbourne

Melbourne, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who are able and willing to provide informed consent
  • Aged 18 to 60 years at the time of consent
  • Have a BMI within the range 18.5 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 a history of any severe allergic reaction or anaphylaxis
  • Have clinically significant abnormalities on clinical laboratory results.
  • Participation in other clinical trials recently/currently

Treatment and study plan

SEP-631

Drug

Oral, tablet

Placebo

Other

Oral, tablet

Primary outcomes

  1. Frequency of treatment emergent adverse events

    Time frame: From enrollment to end of follow up visit, up to approximately 2 months

Secondary outcomes

  1. Plasma PK of SEP-631 after single and multiple doses

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

    Maximum Plasma Concentration (Cmax) of SEP-631

  2. Plasma PK of SEP-631 under fed and fasted conditions

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

    Maximum Plasma Concentration (Cmax) of SEP-631

  3. Plasma PK of SEP-631 after single and multiple doses

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

    Elimination half=life (T 1/2) of SEP-631

  4. Plasma PK of SEP-631 after single and multiple doses

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

    Area Under the Concentration-time Curve (AUC) of SEP-631

  5. Plasma PK of SEP-631 under fed and fasted conditions

    Time frame: From enrollment to end of treatment period, up to approximately 14 days

    Area Under the Concentration-time Curve (AUC) of SEP-631

Sponsors and collaborators

Lead sponsor

Septerna, Inc.

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of SEP-631 in Healthy Adult Volunteers

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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