Clinical trial NCT05909644: An Open-label DDI Study of Omaveloxolone in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: omaveloxolone
DDI
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Celerion
name: Q2 Solutions
name: Altasciences Company Inc.
First posted: 2023-06-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Maximum concentration (Cmax) of omaveloxolone
timeFrame: 43 days
measure: Area under the plasma concentration-time curve from 0 to tlast (AUC0-tlas) of omaveloxolone
timeFrame: 43 days
measure: Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) of omaveloxolone
timeFrame: 43 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
affiliation: Celerion
name: Michelle Valentine, DO
role: PRINCIPAL_INVESTIGATOR
References: