An Open-label DDI Study of Omaveloxolone in Healthy Subjects

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05909644
• Other study ID #: 408-C-2202
• Status: Completed
• Phase: Phase 1
• Start date: July 5, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• Omaveloxolone
Omaveloxolone Capsules, 150 mg, administered orally
• Efavirenz
Efavirenz Tablet, 600 mg, administered orally once daily

Locations

Country	Name	City	State
United States	Celerion, Inc.	Tempe	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen	Altasciences Company Inc., Celerion, Q2 Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-8) 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