Food Effect Study Of AG-013736 In Healthy Volunteers
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
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jun 2009
Shorter than P25 for phase_1 healthy-volunteers
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, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedAugust 4, 2009
August 1, 2009
1 month
June 8, 2009
August 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 months
Secondary Outcomes (2)
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.
2 months
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.
2 months
Study Arms (6)
Sequence 1 (ABC)
OTHERThe following treatments will be administered in the following order A -\> B-\> C 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.
Sequence 2 (ACB)
OTHERThe following treatments will be administered in the following order A -\> C -\> B 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.
Sequence 3 (BCA)
OTHERThe following treatments will be administered in the following order B -\> C -\> A 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.
Sequence 4 (BAC)
OTHERThe following treatments will be administered in the following order B -\> A -\> C 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.
Sequence 5 (CAB)
OTHERThe following treatments will be administered in the following order C -\> A -\> B 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.
Sequence 6 (CBA)
OTHERThe following treatments will be administered in the following order C -\> B -\> A 1. Treatment A = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered after overnight fasting 2. Treatment B = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a high-fat, high-calorie meal. 3. Treatment C = AG-013736 polymorph Form XLI film-coated immediate release (FCIR) tablet administered with a moderate-fat, standard-calorie meal.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, 1070, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 11, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
August 4, 2009
Record last verified: 2009-08