Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
Completed · Phase 1
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00645463
- Run by
- Pfizer
- People needed
- 28
- Starts
- 2007-03-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2009-09-17
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- No clinically relevant abnormalities based upon medical history, physical exam, 12-lead ECG, and clinical lab tests
- Body Mass Index (BMI) \~ 27-40 kg/m2, inclusive
- Personally signed inform consent document
You may not qualify if…
- Evidence or history of significant acute or chronic disease
- Pregnant or nursing females
- Screening PR interval > 220 msec
- Sitting blood pressure <= 90 mmHg systolic or <= 60 mmHg diastolic
Where it is running
- Pfizer Investigational Site — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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