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An Open-label DDI Study of Omaveloxolone in Healthy Subjects

NCT05909644 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-30

No results posted yet for this study

Summary

This is an open-label, single-sequence, 2-period crossover study in healthy subjects.

In this study, 20 subjects will be enrolled to allow at least 16 evaluable subjects.

Subjects will receive a single oral dose of 150 mg omaveloxolone (3 × 50 mg capsules) on Day 1 (Period 1) and on Day 29 (Period 2), and 600 mg efavirenz once a day from Days 15 through 42 (Period 2).

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

Omaveloxolone

Omaveloxolone Capsules, 150 mg, administered orally

DRUG

Efavirenz

Efavirenz Tablet, 600 mg, administered orally once daily

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Q2 Solutions

    collaborator INDUSTRY

  • Altasciences Company Inc.

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Michelle Valentine, DO · Celerion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2023-08-30
Completion
2023-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05909644 on ClinicalTrials.gov