Food Effect Study Of AG-013736 In Healthy Volunteers
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00918632
First received: June 8, 2009
Last updated: August 1, 2009
Last verified: August 2009
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Purpose
The study is designed to evaluate the effect of food on typical blood levels obtained after oral dosing of AG-013736. Drug levels in blood will be compared after an overnight fast and a high-fat, high-calorie meal.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: AG-013736 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Phase I Open-Label Study In Healthy Volunteers To Compare The Plasma Pharmacokinetics of Polymorph Form XLI AG-013736 In The Fasted And Fed State |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To assess the effect of a high-fat, high-calorie meal and overnight fasting on polymorph Form XLI AG-013736 plasma pharmacokinetics following a single 5 mg oral dose in healthy volunteers. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the effect of a moderate-fat, standardized meal and overnight fasting on polymorph Form XLI AG-013736 plasma pharmacokinetics following a single 5 mg oral dose in healthy volunteers. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- To assess the safety and tolerability of single-dose polymorph Form XLI AG-013736 when administered with a high-fat, high-calorie meal, a moderate-fat, standard-calorie meal and overnight fasting in healthy volunteers. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Sequence 1 (ABC)
The following treatments will be administered in the following order A -> B-> C
|
Drug: AG-013736
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> B -> C. Each of these treatments will be separated by a 7 day washout period.
|
|
Sequence 2 (ACB)
The following treatments will be administered in the following order A -> C -> B
|
Drug: AG-013736
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order A -> C -> B. Each of these treatments will be separated by a 7 day washout period.
|
|
Sequence 3 (BCA)
The following treatments will be administered in the following order B -> C -> A
|
Drug: AG-013736
A single dose of an FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> C -> A. Each of these treatments will be separated by a 7 day washout period.
|
|
Sequence 4 (BAC)
The following treatments will be administered in the following order B -> A -> C
|
Drug: AG-013736
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order B -> A -> C. Each of these treatments will be separated by a 7 day washout period.
|
|
Sequence 5 (CAB)
The following treatments will be administered in the following order C -> A -> B
|
Drug: AG-013736
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> A -> B. Each of these treatments will be separated by a 7 day washout period.
|
|
Sequence 6 (CBA)
The following treatments will be administered in the following order C -> B -> A
|
Drug: AG-013736
A single dose of a FCIR tablet of AG-013736 will be administered under overnight fasting (Treatment A), high-fat, high-calorie meal (Treatment B), or moderate-fat, standard-calorie meal (Treatment C) in the following order C -> B -> A. Each of these treatments will be separated by a 7 day washout period.
|
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/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject or a legally acceptable representative.
Exclusion Criteria:
- Evidence of history of clinically significant blood, kidney, endocrine, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Active smokers or users of other tobacco products as well as users of certain drugs.
- Pregnant or nursing females; females of childbearing potential, including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory Follicle-stimulating hormone (FSH) test results at Screening.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00918632 History of Changes |
| Other Study ID Numbers: | A4061053 |
| Study First Received: | June 8, 2009 |
| Last Updated: | August 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
food-effect pharmacokinetics AG-013736 food fasting |
ClinicalTrials.gov processed this record on May 19, 2013