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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00645216
First Posted: March 27, 2008
Last Update Posted: August 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Obesity Drug: CP-945,598 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20. [ Time Frame: 21 days ]
  • Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22 [ Time Frame: 21 days ]
  • Adverse event monitoring throughout duration of the study [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21. [ Time Frame: 2 days ]

Estimated Enrollment: 28
Study Start Date: June 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: CP-945,598 with Grapefruit Juice
CP-945,598 with Grapefruit Juice
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 alone
CP-945,598 alone
Drug: CP-945,598
Subjects take CP-945,598 alone for 21 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645216


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645216     History of Changes
Other Study ID Numbers: A5351047
First Submitted: March 20, 2008
First Posted: March 27, 2008
Last Update Posted: August 10, 2009
Last Verified: March 2008