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NCT00770042 · ClinicalTrials.gov registry record · Phase 1
To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil
A Phase 1 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00770042 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 44 participants.
The verdict
NCT00770042, a Phase 1 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study 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.
Interventions
- DRUG Ritonavir
- DRUG Ketoconazole
- DRUG Erythomycin
- DRUG Avanafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2008-10 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00770042
The ClinicalTrials.gov registry entry for NCT00770042 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VIVUS, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.
NCT00770042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00770042 about?
NCT00770042 is a clinical study titled "To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil". 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 ...
What is the current status of trial NCT00770042?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2008-10. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00770042?
The interventions under investigation include: Ritonavir (DRUG), Ketoconazole (DRUG), Erythomycin (DRUG), Avanafil (DRUG).
Who is sponsoring clinical trial NCT00770042?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
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