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Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
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


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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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: March 2007
Last updated: September 16, 2009

Page last updated: August 23, 2015

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