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Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

Last updated on October 4, 2018

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Study Location
Pfizer Investigational Site
Ann Arbor, Michigan, 48105 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of significant acute or chronic disease

- Pregnant or nursing females

- Screening PR interval > 220 msec

- Sitting blood pressure

NCT00645463
Pfizer
Completed
Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics

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Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obesity
  • 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 A
    Intervention: Drug: CP-945,598
  • Experimental: Group B
    Intervention: Drug: CP-945,598
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00645463
A5351043
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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