Clinical trial NCT03664453: A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers
Official title: A Phase 1, Open-Label, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: omaveloxolone
omaveloxolone capsules
RTA 408
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2018-09-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects.

The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.


Eligibility criteria: Inclusion Criteria:

* Male or female and age is between 18 and 55 years, inclusive;
* All female subjects must have negative results for pregnancy tests performed;
* If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
* If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
* Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator.

Exclusion Criteria:

* Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
* Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis;
* Recent (6-month) history of drug or alcohol abuse;
* Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration;
* Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
* Consumption of alcohol within 72 hours prior to study drug administration;
* Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
* 17.10. Current enrollment in another clinical study.

Primary outcomes:
measure: Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax)
timeFrame: 20 days
measure: Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC)
timeFrame: 20 days
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 6 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
References: