HealthyPhase 1NCT02097329
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
A Phase 1 study testing palbociclib commercial free base, famotidine and rabeprazole in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food. 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 commercial free base, famotidine and rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jun 2014
- 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 of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- 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 diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease).
- Use of tobacco or nicotine containing products within 3 months of screening.
- A positive urine drug screen.
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, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
- Conditions
- Healthy
- Being tested
- palbociclib commercial free base, famotidine, rabeprazole, antacid
- Keywords
- bioavailability, antacid, rabeprazole, famotidine, palbociclib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palbociclib commercial free baseDrug
125 mg oral capsule single dose
famotidineDrug
Also called Pepcid
20 mg oral tablet 10 hours before and 2 hours after palbociclib
rabeprazoleDrug
Also called Aciphex
2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
palbociclib commercial free baseDrug
125 mg oral capsule single dose
antacidDrug
Also called Mi-Acid Maximum Strength Liquid
30 mL orally once (2h before palbociclib)
antacidDrug
Also called Mi-Acid Maximum Strength Liquid
30 mL orally once (2h after palbociclib)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Palbociclib under fed conditions | Experimental | Not described Receives: Drug: palbociclib commercial free base; Drug: famotidine; Drug: rabeprazole |
| Cohort 2: Palbociclib under fed conditions | Experimental | Not described Receives: Drug: palbociclib commercial free base; Drug: antacid |
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: 6 days
Maximum Observed Plasma Concentration (Cmax)
Measured: 6 days
Secondary outcomes (5)
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: 6 days
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: 6 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 6 days
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: 6 days
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT02097329
- Sponsor's protocol ID
- A5481038
- Status last verified
- Jun 2014
- First submitted
- 24 Mar 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02097329
- Acronym / sponsor ID
- A5481038
- Conditions
- Healthy
- Keywords
- bioavailability, antacid, rabeprazole, famotidine, palbociclib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Mar 2014 (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.
To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Palbociclib under fed conditions | Experimental | Drug: palbociclib commercial free base, Drug: famotidine, Drug: rabeprazole |
| Cohort 2: Palbociclib under fed conditions | Experimental | Drug: palbociclib commercial free base, Drug: antacid |
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 of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- 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 diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease).
- Use of tobacco or nicotine containing products within 3 months of screening.
- A positive urine drug screen.
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 commercial free base125 mg oral capsule single dose | Drug | Cohort 1: Palbociclib under fed conditions |
| famotidineAlso: Pepcid20 mg oral tablet 10 hours before and 2 hours after palbociclib | Drug | Cohort 1: Palbociclib under fed conditions |
| rabeprazoleAlso: Aciphex2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib | Drug | Cohort 1: Palbociclib under fed conditions |
| palbociclib commercial free base125 mg oral capsule single dose | Drug | Cohort 2: Palbociclib under fed conditions |
| antacidAlso: Mi-Acid Maximum Strength Liquid30 mL orally once (2h before palbociclib) | Drug | Cohort 2: Palbociclib under fed conditions |
| antacidAlso: Mi-Acid Maximum Strength Liquid30 mL orally once (2h after palbociclib) | Drug | Cohort 2: Palbociclib under fed conditions |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 6 days
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: 6 days
5 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 6 days
Apparent Oral Clearance (CL/F)
Time frame: 6 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 6 days
Apparent Volume of Distribution (Vz/F)
Time frame: 6 days
Plasma Decay Half-Life (t1/2)
Time frame: 6 days
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 19 Jun 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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 commercial free base, famotidine and rabeprazole 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 19 Jun 2014. 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: 6 days). 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?
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 19 Jun 2014.