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

Completed · Phase 1

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00645216

Run by

Pfizer

People needed

28

Starts

2007-06-01

Expected to finish

2007-10-01

Last updated by the study team

2009-08-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female subjects between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 27 to 40 kg/m2.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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