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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Covance Clinical Research Unit (CRU) Inc.
Dallas, Texas, United States
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).
Time frame: 28 days
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).
Time frame: 28 days
Part 2 - Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Time frame: 23 days
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).
Time frame: 23 days
Part 3 - Maximum concentration (Cmax) of omaveloxolone
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Time frame: 23 days
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).
Time frame: 28 days
Part 4 - Maximum concentration (Cmax) of omaveloxolone
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500 mg tablet
10 mg tablet
0.25 mg tablet
600 mg tablet
100 mg capsule
120 mg tablet
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Time frame: 23 days
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).
Time frame: 28 days