Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

September 16, 2009 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: CP-945,598
20 mg CP-945,598 + 240 mg MR Diltiazem
Drug: CP-945,598
20 mg CP-945,598 alone
Experimental: Group B
Drug: CP-945,598
20 mg CP-945,598 + 240 mg MR Diltiazem
Drug: CP-945,598
20 mg CP-945,598 alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)
Time Frame: Days 7 and 28
Days 7 and 28
Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

September 17, 2009

Last Update Submitted That Met QC Criteria

September 16, 2009

Last Verified

March 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • A5351043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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