Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: CP-945,598

• Registration Number: NCT00645463
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study Completion: 2007-06
• Status Verified: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-27
• Last Update Submitted: 2009-09-16
• Last Update Posted: 2009-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	CP-945,598	-
Group A	CP-945,598	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Ann Arbor, Michigan, United States