A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT03664453
• Recruitment Status: Completed
• First Posted: September 10, 2018
• Last Update Posted: August 28, 2019
• Sponsor: Reata Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Reata Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: omaveloxolone	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-Label, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers
• Actual Study Start Date: October 29, 2018
• Actual Primary Completion Date: November 20, 2018
• Actual Study Completion Date: November 20, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Food Effect (Fasted); Subjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fasted state (Period 1) with a crossover and then in the fed state (Period 2). Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2.	Drug: omaveloxolone; Omaveloxolone 50 mg capsules; Other Name: RTA 408
Experimental: Effect (Fed); Subjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fed state (Period 1) with a crossover and then in the fasted state (Period 2). Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2.	Drug: omaveloxolone; Omaveloxolone 50 mg capsules; Other Name: RTA 408
Experimental: Dose Proportionality; Subjects will be randomly assigned to one of two omaveloxolone dosages. A single dose of omaveloxolone (in either 50 mg or 100 mg) will be administered to the subjects in 50 mg capsules in a fasted state. Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 6.	Drug: omaveloxolone; Omaveloxolone 50 mg capsules; Other Name: RTA 408

Outcome Measures

Primary Outcome Measures :

1. Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax) [ Time Frame: 20 days ]
   Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
2. Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC) [ Time Frame: 20 days ]
   Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under curve (AUC).

Secondary Outcome Measures :

1. Incidence of treatment-emergent adverse events [ Time Frame: 6 days ]
   Safety will be assessed based on the number of treatment-emergent adverse events as defined by the Medical Dictionary for Regulatory Activities (MedDRA)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Ohio

Medpace Clinical Pharmacology Unit

Cincinnati, Ohio, United States, 45227

Sponsors and Collaborators

Reata Pharmaceuticals, Inc.

More Information

• Responsible Party: Reata Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03664453
• Other Study ID Numbers: 408-C-1703
• First Posted: September 10, 2018
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reata Pharmaceuticals, Inc.:

omaveloxolone; omaveloxolone capsules; RTA 408