An Open-label DDI Study of Omaveloxolone in Healthy Subjects

• Sponsor: Reata Pharmaceuticals, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05909644
• Collaborator: Celerion (Industry), Q2 Solutions (Industry), altasciences (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 2
• Patients Per Site Per Month: 10

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: Omaveloxolone; Drug: Efavirenz	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omaveloxolone only (Period 1), Then Omaveloxolone and efavirenz (Period 2) 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; Omaveloxolone Capsules, 150 mg, administered orally; Other Names: RTA 408 ; Drug: Efavirenz; Efavirenz Tablet, 600 mg, administered orally once daily

Outcome Measures

Primary Outcome Measures

1. Maximum concentration (Cmax) of omaveloxolone [43 days]

   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.

2. Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone [43 days]

   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.

3. Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone [43 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion, Inc.	Tempe	Arizona	United States	85283

Sponsors and Collaborators

• Reata Pharmaceuticals, Inc.
• Celerion
• Q2 Solutions
• altasciences

Investigators

• Principal Investigator: Michelle Valentine, DO, Celerion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Reata Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT05909644
• Other Study ID Numbers: 408-C-2202
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Reata Pharmaceuticals, Inc.: omaveloxolone; DDI
• Additional relevant MeSH terms: Efavirenz

Study Results

No Results Posted as of Jun 22, 2023