Obesity
Conditions
Brief 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
DRUGCP-945,598
20 mg CP-945,598 + 240 mg MR Diltiazem
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax) | Days 7 and 28 |
| Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests. | 28 days |
Countries
United States
Outcome results
None listed