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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645216
First received: March 20, 2008
Last updated: August 6, 2009
Last verified: March 2008
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Adverse event monitoring throughout duration of the study [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645216     History of Changes
Other Study ID Numbers: A5351047
Study First Received: March 20, 2008
Last Updated: August 6, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 22, 2014