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A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Each subject will receive midazolam on Days 1 and 12. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305. | Up to 17 Days | |
| AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305. | Up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. | Up to 17 days | |
| AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Dickerson, MD | Pharmaceutical Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc., | Lenexa | Kansas | 66219 | United States |
When the clinical study report has been submitted to the appropriate Regulatory authorities, a lay person summary will be provided to all study subjects by mail or email.
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D002110 | Caffeine |
| D000068718 | Rosuvastatin Calcium |
| C000709367 | EDP-305 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Caffeine |
| Drug |
Each subject will receive caffeine on Days 1 and 12. |
|
| Rosuvastatin | Drug | Each subject will receive rosuvastatin on Days 2 and 13. |
|
| EDP-305 | Drug | Each subject will receive EDP-305 on Days 5 through 15. |
|
| Up to 17 days |
| Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. | Up to 17 days |
| t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. | Up to 17 days |
| CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305. | Up to 17 days |
| Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305. | Up to 17 days |
| AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin. | Up to 17 days |
| Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). | Up to 17 days |
| D006571 | Heterocyclic Compounds |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |