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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: Completed Phase 1 study, sponsored by VIVUS.
NCT00770042 is a Phase 1 study that has completed, run by VIVUS. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00770042 record still lists
NCT00770042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.
NCT00770042 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00770042's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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