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Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety

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NCT00645216

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

1. Healthy male and female subjects between the ages of 18 and 55 years.

2. Body Mass Index (BMI) of 27 to 40 kg/m2.

3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other trial procedures.

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

- Non-prescribed use of drugs of abuse/ recreational drugs;

- Recent treatment with experimental drugs or herbal experiments;

- EKG and blood pressure parameters falling outside of protocol-specified limits;

- History of regular alcohol or tobacco use exceeding protocol-specified limits;
grapefruit juice intolerance.

NCT00645216
Pfizer
Completed
Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety

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Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
A Phase 1, Open Label, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Grapefruit Juice On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects
CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obesity
  • Drug: CP-945,598
    Subjects take CP-945,598 alone for 21 days
  • Drug: CP-945,598
    Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21
  • Experimental: CP-945,598 with Grapefruit Juice
    CP-945,598 with Grapefruit Juice
    Intervention: Drug: CP-945,598
  • Experimental: CP-945,598 alone
    CP-945,598 alone
    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
October 2007
Not Provided

Inclusion Criteria:

  1. Healthy male and female subjects between the ages of 18 and 55 years.
  2. Body Mass Index (BMI) of 27 to 40 kg/m2.
  3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

  • Non-prescribed use of drugs of abuse/ recreational drugs;
  • Recent treatment with experimental drugs or herbal experiments;
  • EKG and blood pressure parameters falling outside of protocol-specified limits;
  • History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.
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
 
 
NCT00645216
A5351047
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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1-800-718-1021

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[email protected]



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