A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone

Healthy Adult Subjects Clinical Trial

Official title:

A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008186
• Other study ID #: 408-C-1806
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2019
• Est. completion date: August 28, 2019

Study information

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

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 28, 2019
• Est. primary completion date: August 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• Omaveloxolone
50 mg capsules
• Midazolam oral solution
2 mg/mL oral solution
• Repaglinide 1 MG
1 mg tablet
• MetFORMIN 500 Mg Oral Tablet
500 mg tablet
• Rosuvastatin
10 mg tablet
• Digoxin tablet
0.25 mg tablet
• Gemfibrozil Tablets
600 mg tablet
• Itraconazole capsule
100 mg capsule
• Verapamil Pill
120 mg tablet

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit (CRU) Inc.	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen	Covance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)	Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax).	28 days
Primary	Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)	Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine area under the curve (AUC).	28 days
Primary	Part 2 - Maximum concentration (Cmax) of omaveloxolone	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).	23 days
Primary	Part 2 - Area under the omaveloxolone concentration-time curve (AUC)	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).	23 days
Primary	Part 3 - Maximum concentration (Cmax) of omaveloxolone	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).	23 days
Primary	Part 3 - Area under the omaveloxolone concentration-time curve (AUC)	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).	28 days
Primary	Part 4 - Maximum concentration (Cmax) of omaveloxolone	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).	23 days
Primary	Part 4 - Area under the omaveloxolone concentration-time curve (AUC)	Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).	28 days