An Open-label DDI Study of Omaveloxolone in Healthy Subjects

NCT05909644 | Completed Phase 1 FDA Drug

• 1 other identifier: 408-C-2202
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

omaveloxolone; DDI

Outcome Measures

Primary Outcomes (3)

• Maximum concentration (Cmax) of omaveloxolone

  Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study.

  43 days

• Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone

  Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study.

  43 days

• Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone

  Blood samples to assess omaveloxolone PK will be collected predose and at the specified time points over a 336-hour period following each omaveloxolone dose for the duration of the study.

  43 days

Study Arms (1)

Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2)

EXPERIMENTAL

Period 1 (Day 1 - 15): Omaveloxolone Capsules, 150 mg, administered orally in a single dose on Day 1 Period 2 (Day 15 - 43): Efavirenz Tablet, 600 mg, administered orally once daily from Day 15 - Day 42 and Omaveloxolone Capsules, 150 mg, administered orally in a single dose on Day 29

Drug: Omaveloxolone; Drug: Efavirenz

Interventions

Omaveloxolone DRUG

Omaveloxolone Capsules, 150 mg, administered orally

Also known as: RTA 408

Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2)

Efavirenz DRUG

Efavirenz Tablet, 600 mg, administered orally once daily

Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening.
• BMI at screening between 18.0 and 32.0 kg/m2 (inclusive)
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
• Use of any prescription medication before the first study drug administration (within 14 days before initial study drug administration or within 5 half-lives of the prescription medication, whichever is longer), and until after the last protocol-specified blood sample is prohibited, other than use of hormonal contraception.
• Clinically significant abnormal 12 lead ECGs
• Personal history of unexplained syncopal events, or family history of long QT syndrome or sudden unexplained death in a young person.
• Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• History of drug or alcohol abuse in the last 6 months
• Positive hepatitis panel and/or positive human immunodeficiency virus test.
• Presence of hypotension (diastolic blood pressure ≤50 mmHg, systolic blood pressure ≤90 mmHg) or hypertension (diastolic blood pressure ≥ 140 mmHg, systolic blood pressure ≥ 90 mmHg)
• Blood donation (excluding plasma donation) within 56 days prior to screening and plasma donation within 7 days before screening.
• Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.

Sponsors & Collaborators

• Biogen: lead
• Celerion: collaborator
• Q2 Solutions: collaborator
• Altasciences Company Inc.: collaborator

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

omaveloxolone; efavirenz

Study Officials

• Michelle Valentine, DO

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 5, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)