Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664453
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

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

Layout table for study information
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

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




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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664453


Locations
Layout table for location information
United States, Ohio
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.

Layout table for additonal information
Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03664453     History of Changes
Other Study ID Numbers: 408-C-1703
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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