A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664453
• Other study ID #: 408-C-1703
• Status: Completed
• Phase: Phase 1
• Start date: October 29, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• omaveloxolone
Omaveloxolone 50 mg capsules

Locations

Country	Name	City	State
United States	Medpace Clinical Pharmacology Unit	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax)	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).	20 days
Primary	Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC)	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under curve (AUC).	20 days
Secondary	Incidence of treatment-emergent adverse events	Safety will be assessed based on the number of treatment-emergent adverse events as defined by the Medical Dictionary for Regulatory Activities (MedDRA)	6 days