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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omaveloxolone and Multiple Drugs (Part 1) | Experimental | Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27 |
|
| Omaveloxolone & Gemfibrozil (Part 2) | Experimental | Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 600 mg gemfibrozil (twice daily) on Days 10 to 18 |
|
| Omaveloxolone and Itraconazole (Part 3) | Experimental | Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18. |
|
| Omaveloxolone and Verapamil (Part 4) | Experimental | Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omaveloxolone | Drug | 50 mg capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Part 2 - Maximum concentration (Cmax) of omaveloxolone | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). | 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). | 23 days |
| Part 3 - Maximum concentration (Cmax) of omaveloxolone | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). | 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). |
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Inclusion Criteria:
Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:
Exclusion Criteria:
Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Zon, MD | Covance CRU Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit (CRU) Inc. | Dallas | Texas | 75247 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| C000589490 | omaveloxolone |
| D008874 | Midazolam |
| C072379 | repaglinide |
| D008687 | Metformin |
| D013607 | Tablets |
| D000068718 | Rosuvastatin Calcium |
| D004077 | Digoxin |
| D015248 | Gemfibrozil |
| D017964 | Itraconazole |
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam oral solution | Drug | 2 mg/mL oral solution |
|
| Repaglinide 1 MG | Drug | 1 mg tablet |
|
| MetFORMIN 500 Mg Oral Tablet | Drug | 500 mg tablet |
|
| Rosuvastatin | Drug | 10 mg tablet |
|
| Digoxin tablet | Drug | 0.25 mg tablet |
|
| Gemfibrozil Tablets | Drug | 600 mg tablet |
|
| Itraconazole capsule | Drug | 100 mg capsule |
|
| Verapamil Pill | Drug | 120 mg tablet |
|
| 28 days |
| Part 4 - Maximum concentration (Cmax) of omaveloxolone | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). | 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). | 28 days |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D014230 | Triazoles |
| D001393 | Azoles |
| D010879 | Piperazines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |