An Open-label, Single Sequence, 2-period Crossover DDI Study of Omaveloxolone in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Reata Pharmaceuticals, Inc.
• Collaborators: altasciences; Celerion; Q2 Solutions
• Treatments: Efavirenz

Criteria

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.