Clinical trial NCT04008186: A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone
Official title: A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: RTA 408
RTA 408 capsules
omaveloxolone
omaveloxolone capsules
DDI
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Covance
First posted: 2019-07-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.


Eligibility criteria: Inclusion Criteria:

Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:

* Males or females, of any race, between 18 and 55 years of age, inclusive.
* Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight \>50 kg.
* In good health.
* 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:

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:

* 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).
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
* History of alcoholism or drug/chemical abuse within 2 years prior to Check in (Day 1).
* Abnormal laboratory values considered clinically significant by the investigator
* 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.
* Pulse rate \<50 bpm or systolic blood pressure \<110 mmHg.
* Alcohol consumption of \>21 units per week for males and \>14 units for females.
* Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.
* Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half lives (if known), whichever is longer, prior to dosing.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
* Have previously completed or withdrawn from this study or any other study investigating omaveloxolone, and have previously received the investigational product.
* Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Primary outcomes:
measure: Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
timeFrame: 28 days
measure: Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
timeFrame: 28 days
measure: Part 2 - Maximum concentration (Cmax) of omaveloxolone
timeFrame: 23 days
measure: Part 2 - Area under the omaveloxolone concentration-time curve (AUC)
timeFrame: 23 days
measure: Part 3 - Maximum concentration (Cmax) of omaveloxolone
timeFrame: 23 days
measure: Part 3 - Area under the omaveloxolone concentration-time curve (AUC)
timeFrame: 28 days
measure: Part 4 - Maximum concentration (Cmax) of omaveloxolone
timeFrame: 23 days
measure: Part 4 - Area under the omaveloxolone concentration-time curve (AUC)
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit (CRU) Inc.
state: Texas
Study officials:
affiliation: Covance CRU Inc.
name: Jennifer Zon, MD
role: PRINCIPAL_INVESTIGATOR
References: