Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00645463

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: CP-945,598	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Verapamil Diltiazem hydrochloride Dexverapamil Diltiazem Diltiazem malate Verapamil hydrochloride

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax) [ Time Frame: Days 7 and 28 ] [ Designated as safety issue: No ]
Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	March 2007
Study Completion Date:	June 2007

Arms	Assigned Interventions
Experimental: Group A	Drug: CP-945,598 20 mg CP-945,598 + 240 mg MR Diltiazem
Experimental: Group B	Drug: CP-945,598 20 mg CP-945,598 alone

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645463

Locations

United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48105

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00645463 History of Changes
Other Study ID Numbers:	A5351043
Study First Received:	March 21, 2008
Last Updated:	September 16, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diltiazem
Verapamil
Calcium Channel Blockers

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 09, 2012