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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00645216
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: CP-945,598; Drug: CP-945,598	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jun 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CP-945,598 with Grapefruit Juice CP-945,598 with Grapefruit Juice	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 CP-945,598 alone	Drug: CP-945,598; Subjects take CP-945,598 alone for 21 days

Outcome Measures

Primary Outcome Measures

1. 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]

2. Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22 [21 days]

3. Adverse event monitoring throughout duration of the study [21 days]

Secondary Outcome Measures

1. Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21. [2 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00645216
• Other Study ID Numbers: A5351047
• First Posted: Mar 27, 2008
• Last Update Posted: Aug 10, 2009
• Last Verified: Mar 1, 2008

Study Results

No Results Posted as of Aug 10, 2009