HealthyPhase 1NCT01904747
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption
A Phase 1 study testing Palbociclib administered Fasted, Palbociclib administered Fed high calorie and Palbociclib administered Fed low calorie in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study is intended to quantify the effect of food on the extent of absorption of palbociclib. The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Palbociclib administered Fasted, Palbociclib administered Fed high calorie and Palbociclib administered Fed low calorie
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Oct 2013
- 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 subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Any condition possibly affecting drug absorption
- Male subjects who are unwilling or unable to use a highly effective method of contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Effect Of Food On The Bioavailability Of Palbociclib
This study is intended to quantify the effect of food on the extent of absorption of palbociclib.
The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug.
Read more
High and low calorie meals will be given to the subjects 30 minutes before palbociclib administration as 2 of the 3 conditions to compare with completely absence of food in the body when dosing (fasted).The third condition to test and compare with fasted stage will be the administration of food before and after palbociclib administration.
This information will help the program to decide wether or not the presence of food when dosing palbociclib help with its absorption and to what extent it does help. Based on the collected information, a recommendation about the administration of palbociclib with food will be provided to patients.
- Conditions
- Healthy
- Being tested
- Palbociclib administered Fasted, Palbociclib administered Fed high calorie, Palbociclib administered Fed low calorie, Palbociclib administered Fed moderate calorie
- Keywords
- Food, Bioavailability, Fasted, Fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib administered FastedDrug
palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose
Palbociclib administered Fed high calorieDrug
palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose
Palbociclib administered Fed low calorieDrug
palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose
Palbociclib administered Fed moderate calorieDrug
palbociclib given between moderate calorie meal; capsule form, 125 mg single dose
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib given to healthy volunteers | Experimental | Not described Receives: Drug: Palbociclib administered Fasted; Drug: Palbociclib administered Fed high calorie; Drug: Palbociclib administered Fed low calorie; Drug: Palbociclib administered Fed moderate calorie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Measured: 144 hrs
Maximum Observed Plasma Concentration (Cmax)
Measured: 144 hrs
Secondary outcomes (7)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 144 hrs
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Measured: 144 hrs
Area under the Concentration-Time Curve (AUC) from 0 to 72 hrs
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: 144 hrs
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: 144 hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 144 hrs
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: 144 hrs
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 144 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904747
- Sponsor's protocol ID
- A5481021
- Status last verified
- Dec 2013
- First submitted
- 1 Jul 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruiz-Garcia A, Plotka A, O'Gorman M, Wang DD. Effect of food on the bioavailability of palbociclib. Cancer Chemother Pharmacol. 2017 Mar;79(3):527-533. doi: 10.1007/s00280-017-3246-4. Epub 2017 Feb 15.
PubMed 28204912
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Estimate The Effect Of Food On The Bioavailability Of Palbociclib
- ClinicalTrials.gov ID
- NCT01904747
- Acronym / sponsor ID
- A5481021
- Conditions
- Healthy
- Keywords
- Food, Bioavailability, Fasted, Fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Jul 2013 (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.
This study is intended to quantify the effect of food on the extent of absorption of palbociclib.
The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug.
High and low calorie meals will be given to the subjects 30 minutes before palbociclib administration as 2 of the 3 conditions to compare with completely absence of food in the body when dosing (fasted).The third condition to test and compare with fasted stage will be the administration of food before and after palbociclib administration.
This information will help the program to decide wether or not the presence of food when dosing palbociclib help with its absorption and to what extent it does help. Based on the collected information, a recommendation about the administration of palbociclib with food will be provided to patients.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib given to healthy volunteers | Experimental | Drug: Palbociclib administered Fasted, Drug: Palbociclib administered Fed high calorie, Drug: Palbociclib administered Fed low calorie, Drug: Palbociclib administered Fed moderate calorie |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- Any condition possibly affecting drug absorption
- Male subjects who are unwilling or unable to use a highly effective method of contraception
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 |
|---|---|---|
| Palbociclib administered Fastedpalbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose | Drug | Palbociclib given to healthy volunteers |
| Palbociclib administered Fed high caloriepalbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose | Drug | Palbociclib given to healthy volunteers |
| Palbociclib administered Fed low caloriepalbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose | Drug | Palbociclib given to healthy volunteers |
| Palbociclib administered Fed moderate caloriepalbociclib given between moderate calorie meal; capsule form, 125 mg single dose | Drug | Palbociclib given to healthy volunteers |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 144 hrs
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 144 hrs
7 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 144 hrs
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: 144 hrs
Area under the Concentration-Time Curve (AUC) from 0 to 72 hrs
Time frame: 144 hrs
Apparent Oral Clearance (CL/F)
Time frame: 144 hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 144 hrs
Apparent Volume of Distribution (Vz/F)
Time frame: 144 hrs
Plasma Decay Half-Life (t1/2)
Time frame: 144 hrs
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 17 Dec 2013.
- Derived from this study: PubMed 28204912Ruiz-Garcia A, Plotka A, O'Gorman M, Wang DD. Effect of food on the bioavailability of palbociclib. Cancer Chemother Pharmacol. 2017 Mar;79(3):527-533. doi: 10.1007/s00280-017-3246-4. Epub 2017 Feb 15.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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 Palbociclib administered Fasted, Palbociclib administered Fed high calorie and Palbociclib administered Fed low calorie in people with Healthy, run by Pfizer at 1 site in United States.
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 17 Dec 2013. 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 United States. 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?
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] (time frame: 144 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904747, which also lists 1 linked publication.
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 17 Dec 2013.