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N/A

Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) for Healthy Adult Subjects

Phase 1
Waitlist Available
Led By Michelle Valentine, DO
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 43 days
Awards & highlights

Study Summary

This trial tests how a single oral dose of a drug affects healthy subjects over a 42-day period. 20 people will take the drug and its effects will be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~43 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 43 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone
Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone
Maximum concentration (Cmax) of omaveloxolone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2)Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omaveloxolone
2019
Completed Phase 1
~120
Efavirenz
2005
Completed Phase 4
~11160

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,416 Total Patients Enrolled
2 Trials studying Healthy Adult Subjects
158 Patients Enrolled for Healthy Adult Subjects
Reata Pharmaceuticals, Inc.Lead Sponsor
51 Previous Clinical Trials
6,880 Total Patients Enrolled
1 Trials studying Healthy Adult Subjects
61 Patients Enrolled for Healthy Adult Subjects
altasciencesUNKNOWN
2 Previous Clinical Trials
119 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being accepted into this experimentation?

"As outlined in the study's inclusion guidelines, only persons between 18 and 55 years old can enroll as participants."

Answered by AI

Are the two phases of this medication regimen – Omaveloxolone alone and Omaveloxolone combined with efavirenz – sanctioned by the FDA?

"The safety rating of Omaveloxolone in isolation (Period 1), followed by a combination with efavirenz during Period 2, was conservatively evaluated as a score of 1. This reflects that the current phase is only Phase I and there is limited data available to assess efficacy or safety."

Answered by AI

Does my profile fit the criteria to participate in this experiment?

"To be eligible for this study, prospective participants must meet the criteria of an adult between 18 and 55 years old. The trial is seeking to recruit roughly 20 people in total."

Answered by AI

Is there still accommodation available for participants in this research?

"Based on the information regarding this medical trial found on clinicaltrials.gov, recruitement has been closed since June 8th 2023. Although no more patients are being accepted for this study, 3 other trials with similar objectives remain open to enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
Florida
What site did they apply to?
Celerion, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Looking for paid studies.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
An Open-label DDI Study of Omaveloxolone in Healthy Subjects
2023. "An Open-label DDI Study of Omaveloxolone in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05909644.
~11 spots leftby Apr 2025
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