Healthy VolunteersPhase 1NCT00918632
Food Effect Study Of AG-013736 In Healthy Volunteers
A Phase 1 study testing AG-013736 in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AG-013736
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- AG-013736
- Keywords
- food-effect pharmacokinetics AG-013736 food fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-013736Drug
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.
AG-013736Drug
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.
AG-013736Drug
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.
AG-013736Drug
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.
AG-013736Drug
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.
AG-013736Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (ABC) | Other | The 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. Receives: Drug: AG-013736 |
| Sequence 2 (ACB) | Other | The 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. Receives: Drug: AG-013736 |
| Sequence 3 (BCA) | Other | The 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. Receives: Drug: AG-013736 |
| Sequence 4 (BAC) | Other | The 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. Receives: Drug: AG-013736 |
| Sequence 5 (CAB) | Other | The 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. Receives: Drug: AG-013736 |
| Sequence 6 (CBA) | Other | The 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. Receives: Drug: AG-013736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918632
- Sponsor's protocol ID
- A4061053
- Status last verified
- Aug 2009
- First submitted
- 8 Jun 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00918632
- Acronym / sponsor ID
- A4061053
- Conditions
- Healthy Volunteers
- Keywords
- food-effect pharmacokinetics AG-013736 food fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (ABC) | Other | Drug: AG-013736The 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) | Other | Drug: AG-013736The 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) | Other | Drug: AG-013736The 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) | Other | Drug: AG-013736The 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) | Other | Drug: AG-013736The 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) | Other | Drug: AG-013736The 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG-013736A 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. | Drug | Sequence 1 (ABC) |
| AG-013736A 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. | Drug | Sequence 2 (ACB) |
| AG-013736A 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. | Drug | Sequence 3 (BCA) |
| AG-013736A 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. | Drug | Sequence 4 (BAC) |
| AG-013736A 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. | Drug | Sequence 5 (CAB) |
| AG-013736A 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. | Drug | Sequence 6 (CBA) |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG-013736 in people with Healthy Volunteers, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.