Healthy Adult Subjects
Conditions
Keywords
RTA 408, RTA 408 capsules, omaveloxolone, omaveloxolone capsules, DDI
Brief 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.
Interventions
DRUGOmaveloxolone
50 mg capsules
2 mg/mL oral solution
DRUGRepaglinide 1 MG
1 mg tablet
500 mg tablet
DRUGRosuvastatin
10 mg tablet
DRUGDigoxin tablet
0.25 mg tablet
600 mg tablet
100 mg capsule
DRUGVerapamil Pill
120 mg tablet
Sponsors
Covance
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin) | 28 days | Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax). |
| Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin) | 28 days | Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine area under the curve (AUC). |
| Part 2 - Maximum concentration (Cmax) of omaveloxolone | 23 days | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). |
| Part 2 - Area under the omaveloxolone concentration-time curve (AUC) | 23 days | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC). |
| Part 3 - Maximum concentration (Cmax) of omaveloxolone | 23 days | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). |
| Part 3 - Area under the omaveloxolone concentration-time curve (AUC) | 28 days | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC). |
| Part 4 - Maximum concentration (Cmax) of omaveloxolone | 23 days | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). |
| Part 4 - Area under the omaveloxolone concentration-time curve (AUC) | 28 days | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC). |
Countries
United States
Outcome results
None listed