Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: CP-945,598 (Drug); CP-945,598 (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Phase 1, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Modified Release Diltiazem On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Ann Arbor, Michigan 48105, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2007
Ending date: June 2007
Last updated: March 21, 2008
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