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

NCT00645216

Last updated date
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 21, 2008)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645216
Other Study ID Numbers  ICMJE A5351047
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP