NCT07433179

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
8mo left

Started Mar 2026

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

March 4, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

February 19, 2026

Last Update Submit

April 17, 2026

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Frequency of treatment emergent adverse events

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

Secondary Outcomes (5)

  • 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 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

  • 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

Study Arms (3)

Single Ascending Dose

EXPERIMENTAL
Drug: SEP-479Other: Placebo

Multiple Ascending Dose

EXPERIMENTAL
Drug: SEP-479Other: Placebo

Food Effect

EXPERIMENTAL
Drug: SEP-479

Interventions

SEP-479DRUG

Oral, capsule

Food EffectMultiple Ascending DoseSingle Ascending Dose
PlaceboOTHER

Oral, capsule

Multiple Ascending DoseSingle Ascending Dose

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Australia

RECRUITING

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

March 4, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

AU(1)