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NCT00645463 · ClinicalTrials.gov registry record · Phase 1
Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00645463: Completed Phase 1 study, sponsored by Pfizer.
NCT00645463 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00645463, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A inhibitors needs to be characterized to support labeling and registration. Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased risk of hypertension and cardiovascular disease in the obese patient population.
Interventions
- DRUG CP-945,598
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-06 |
| Phase | Phase 1 |
What the finished NCT00645463 record still lists
NCT00645463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which CP-945,598 is the first listed.
NCT00645463 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00645463 about?
NCT00645463 is a clinical study titled "Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics". A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in Cmax. Therefore, the sens...
What is the current status of trial NCT00645463?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2007-03. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00645463?
The interventions under investigation include: CP-945,598 (DRUG).
Who is sponsoring clinical trial NCT00645463?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00645463's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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