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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 28 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00645463
The ClinicalTrials.gov registry entry for NCT00645463 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CP-945,598 is the first listed.
NCT00645463 reports 0 study locations.
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.
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