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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CP-945,598 with Grapefruit Juice

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Subjects take CP-945,598 from Days 1 to 7, then take CP-945,598 and Grapefruit Juice from Days 8 to 21

CP-945,598 alone

Group Type EXPERIMENTAL

CP-945,598

Intervention Type DRUG

Subjects take CP-945,598 alone for 21 days

Interventions

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CP-945,598

Subjects take CP-945,598 alone for 21 days

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes