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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: CP-945,598

• Registration Number: NCT00645216
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study Completion: 2007-10
• Status Verified: 2008-03
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-27
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CP-945,598 with Grapefruit Juice	CP-945,598	CP-945,598 with Grapefruit Juice
CP-945,598 alone	CP-945,598	CP-945,598 alone

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States