drugset / Trial / NCT00770042
To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil
RandomizedCrossoverOpen-labelTreatment
Summary
This study is being conducted to examine the effect of three CYP3A4 inhibitors (ketoconazole, erythromycin and ritonavir) on the single dose pharmacokinetics of avanafil. Ketoconazole and ritonavir are potent inhibitors of CYP3A4 and erythromycin is a moderate CYP3A4 inhibitor. Any interaction that is observed would be predictive of other inhibitors of CYP3A4.
Timeline
- Start
- 2008-10
- Primary completion
- 2008-11
- Completion
- 2008-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avanafil | Small molecule | 50 mg | — |
| Subject | Avanafil | Small molecule | 200 mg | — |
| Subject | Erythromycin | Small molecule | 500 mg | — |
| Subject | Ketoconazole | Small molecule | 400 mg | — |
| Subject | Ritonavir | Other / unclassified | 600 mg | — |