Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 obesity
Started Jun 2007
Shorter than P25 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedAugust 10, 2009
March 1, 2008
March 20, 2008
August 6, 2009
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.
2 days
Study Arms (2)
CP-945,598 with Grapefruit Juice
EXPERIMENTALCP-945,598 with Grapefruit Juice
CP-945,598 alone
EXPERIMENTALCP-945,598 alone
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2008
First Posted
March 27, 2008
Study Start
June 1, 2007
Study Completion
October 1, 2007
Last Updated
August 10, 2009
Record last verified: 2008-03