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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: CP-945,598; Drug: CP-945,598

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CP-945,598 with Grapefruit Juice	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 alone	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	21 days
Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22	21 days
Adverse event monitoring throughout duration of the study	21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.	2 days

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: March 20, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Estimate): August 10, 2009
• Last Update Submitted That Met QC Criteria: August 6, 2009
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: A5351047