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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: CP-945,598

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645216

A5351047

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

CP-945,598 with Grapefruit Juice

Experimental group

Description:

CP-945,598 with Grapefruit Juice

Treatment:

Drug: CP-945,598

Drug: CP-945,598

CP-945,598 alone

Experimental group

Description:

CP-945,598 alone

Treatment:

Drug: CP-945,598

Drug: CP-945,598