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
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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014