HealthyPhase 1NCT02311946
A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
A Phase 1 study testing Palbociclib Alone and Palbociclib + Rabeprazole in people with Healthy, run by Pfizer at 3 sites in United States.
Trial summary
This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations. 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 Alone and Palbociclib + Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to Apr 2015
- 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 or Female of non-childbearing potential,
- Having a body weight >50 kg
- Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2.
Who cannot join
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- A positive urine drug or cotinine test
- A known history of hypersensitivity to palbociclib
- A supine systolic blood pressure >140 mmHg, or a QTc >450 msec.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MRA Clinical Research - Phase 1
Miami, Florida, 33143
Miami Research Associates, LLC
South Miami, Florida, 33143
MRA Clinical Research, LLC
South Miami, Florida, 33143
About this study
Official title: A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib (pd-0332991) In Healthy Volunteers To Estimate The Effect Of Antacid Treatment On The Bioavailability Of A 125 Mg Single Dose Of Six Experimental Formulations Of Palbociclib Relative To Palbociclib Administration Alone Under Fasted Conditions
This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.
Read the detailed description
This will be a 6 cohort study investigating one experimental formulation of palbociclib in each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days, and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a single 125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood sampling up to 120 hours post-dose.
- Conditions
- Healthy
- Being tested
- Palbociclib Alone, Palbociclib + Rabeprazole
- Keywords
- Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib AloneDrug
Also called Palbociclib, PD-0332991
In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
Palbociclib + RabeprazoleDrug
Also called Palbociclib, PD-0332991, Rabeprazole, Aciphex, Proton Pump Inhibitor, PPI
In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will receive a 125 mg round yellow palbociclib tablet containing succinic acid Receives: Drug: Palbociclib Alone; Drug: Palbociclib + Rabeprazole |
| Cohort 2 | Experimental | Cohort 2 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet containing HMPC E3 Receives: Drug: Palbociclib Alone; Drug: Palbociclib + Rabeprazole |
| Cohort 3 | Experimental | Cohort 3 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet with HMPC E3 and succinic acid. Receives: Drug: Palbociclib Alone; Drug: Palbociclib + Rabeprazole |
| Cohort 4 | Experimental | Cohort 4 will receive a 125 mg oval white/yellow palbociclib bilayer tablet with tartaric and succinic acid. Receives: Drug: Palbociclib Alone; Drug: Palbociclib + Rabeprazole |
| Cohort 5 | Experimental | Cohort 5 will receive a 125 mg oval yellow palbociclib fluid bed granulation tablet with succinic acid. Receives: Drug: Palbociclib Alone; Drug: Palbociclib + Rabeprazole |
| Cohort 6 | Experimental | Cohort 6 will receive a 125 mg palbociclib oral solution Receives: Drug: Palbociclib Alone; Drug: Palbociclib + Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCinf
Area under the concentration-time curve from time zero to infinity.
Measured: Pre-dose to 120 hours post-dose
Cmax
Maximum observed plasma concentration
Measured: Pre-dose to 120 hours post-dose
Secondary outcomes (5)
AUClast
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration.
Measured: Pre-dose to 120 hours post-dose
CL/F
Apparent oral clearance from plasma
Measured: Pre-dose to 120 hours post-dose
Tmax
Time of the maximum observed concentration post-dose.
Measured: Pre-dose to 120 hours post-dose
Vz/F
Apparent volume of distribution
Measured: Pre-dose to 120 hours post-dose
t1/2
Terminal phase half-life
Measured: Pre-dose to 120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionApr 2015
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT02311946
- Sponsor's protocol ID
- A5481041
- Status last verified
- May 2015
- First submitted
- 4 Dec 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib (pd-0332991) In Healthy Volunteers To Estimate The Effect Of Antacid Treatment On The Bioavailability Of A 125 Mg Single Dose Of Six Experimental Formulations Of Palbociclib Relative To Palbociclib Administration Alone Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT02311946
- Acronym / sponsor ID
- A5481041
- Conditions
- Healthy
- Keywords
- Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Dec 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.
This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.
Detailed description
This will be a 6 cohort study investigating one experimental formulation of palbociclib in each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days, and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a single 125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood sampling up to 120 hours post-dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Palbociclib Alone, Drug: Palbociclib + RabeprazoleCohort 1 will receive a 125 mg round yellow palbociclib tablet containing succinic acid |
| Cohort 2 | Experimental | Drug: Palbociclib Alone, Drug: Palbociclib + RabeprazoleCohort 2 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet containing HMPC E3 |
| Cohort 3 | Experimental | Drug: Palbociclib Alone, Drug: Palbociclib + RabeprazoleCohort 3 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet with HMPC E3 and succinic acid. |
| Cohort 4 | Experimental | Drug: Palbociclib Alone, Drug: Palbociclib + RabeprazoleCohort 4 will receive a 125 mg oval white/yellow palbociclib bilayer tablet with tartaric and succinic acid. |
| Cohort 5 | Experimental | Drug: Palbociclib Alone, Drug: Palbociclib + RabeprazoleCohort 5 will receive a 125 mg oval yellow palbociclib fluid bed granulation tablet with succinic acid. |
| Cohort 6 | Experimental | Drug: Palbociclib Alone, Drug: Palbociclib + RabeprazoleCohort 6 will receive a 125 mg palbociclib oral solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Male or Female of non-childbearing potential,
- Having a body weight >50 kg
- Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2.
Key exclusion criteria (4 listed)
- Any condition possibly affecting drug absorption (eg, gastrectomy)
- A positive urine drug or cotinine test
- A known history of hypersensitivity to palbociclib
- A supine systolic blood pressure >140 mmHg, or a QTc >450 msec.
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 AloneAlso: Palbociclib, PD-0332991In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| Palbociclib + RabeprazoleAlso: Palbociclib, PD-0332991, Rabeprazole, Aciphex, Proton Pump Inhibitor, PPIIn Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
AUCinf
Time frame: Pre-dose to 120 hours post-dose
Area under the concentration-time curve from time zero to infinity.
Cmax
Time frame: Pre-dose to 120 hours post-dose
Maximum observed plasma concentration
5 secondary outcomes
AUClast
Time frame: Pre-dose to 120 hours post-dose
CL/F
Time frame: Pre-dose to 120 hours post-dose
Tmax
Time frame: Pre-dose to 120 hours post-dose
Vz/F
Time frame: Pre-dose to 120 hours post-dose
t1/2
Time frame: Pre-dose to 120 hours post-dose
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 28 May 2015.
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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
3 sites 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 Alone and Palbociclib + Rabeprazole in people with Healthy, run by Pfizer at 3 sites 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 4 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
AUCinf (time frame: Pre-dose to 120 hours post-dose). 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 28 May 2015.