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This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRD-740 | Other | CRD-740 single dose administered alone |
|
| CRD-740 and Itraconazole | Other | CRD-740 single dose administered with Itraconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRD-740 | Drug | CRD-740 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24 of CRD-740 alone and with coadministration of itraconazole | Day 1 to Day 16 | |
| AUC0-inf of CRD-740 alone and with coadministration of itraconazole | Day 1 to Day 16 | |
| AUC0-t of CRD-740 alone and with coadministration of itraconazole | Day 1 to Day 16 | |
| Cmax of CRD-740 alone and with coadministration of itraconazole | Day 1 to Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Half life (t1/2) of CRD-740 | Day 1 to Day 16 | |
| Time to maximum concentration (Tmax) of CRD-740 | Day 1 to Day 16 | |
| Oral clearance (CL/F) of CRD-740 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardurion Investigative Site | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole |
| Drug |
Itraconazole |
|
| Day 1 to Day 16 |
| Apparent volume of distribution during terminal phase (Vz/F) of CRD-740 | Day 1 to Day 16 |
| D010879 |
| Piperazines |