Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645216
First received: March 20, 2008
Last updated: August 6, 2009
Last verified: March 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: CP-945,598 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Adverse event monitoring throughout duration of the study [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21. [ Time Frame: 2 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 28 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00645216 History of Changes |
| Other Study ID Numbers: | A5351047 |
| Study First Received: | March 20, 2008 |
| Last Updated: | August 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013