Healthy Adult Subjects
Conditions
Keywords
omaveloxolone, DDI
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).
Interventions
DRUGOmaveloxolone
Omaveloxolone Capsules, 150 mg, administered orally
DRUGEfavirenz
Efavirenz Tablet, 600 mg, administered orally once daily
Sponsors
Celerion
Q2 Solutions
Altasciences Company Inc.
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed