Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
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About
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.
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Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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