HealthyPhase 1NCT02059330
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
A Phase 1 study testing Palbociclib 75mg, Palbociclib 125mg and Palbociclib 100mg in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. 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 75mg, Palbociclib 125mg and Palbociclib 100mg
- 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
- Mar 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
- Subjects must be a healthy male or female of non-childbearing potential
- Subjects must have a BMI (Body Mass Index) between 17.5 and 30.5 kg/m2
- To be eligible for the Japanese cohort, subjects must have 4 biological grandparents who are Japanese that were born in Japan
Who cannot join
- Any condition affecting drug absorption (eg gastrectomy, achlorhydria, etc)
- Use of prescription or non-prescription drugs
- A QTc-interval >450msec or a QRS interval >120msec
- Pregnant or breastfeeding females, females of childbearing potential, and males who are unwilling or unable to use an effective method of contraception for the duration of the study and for 90 days after the last dose of palbociclib in the study
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 Study To Investigate The Effect Of Dose And Ethnicity On Palbociclib (PD-0332991) Pharmacokinetics In Japanese Healthy Volunteers
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, this study will investigate the effect of Japanese ethnicity of palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian subjects.
- Conditions
- Healthy
- Being tested
- Palbociclib 75mg, Palbociclib 125mg, Palbociclib 100mg, Palbociclib
- Keywords
- Japanese PK-Bridging Study, dose-proportionality study, Palbociclib, PD-0332991, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib 75mgDrug
Also called PD-0332991
In Period 1, Japanese subjects will receive a single oral 75mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
Palbociclib 125mgDrug
Also called PD-0332991
In Period 2, Japanese subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
Palbociclib 100mgDrug
Also called PD-0332991
In Period 3, Japanese subjects will receive a single oral 100mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
PalbociclibDrug
Also called PD-0332991
In Period 4, Japanese subjects will receive a single oral dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. The amount of the dose will be determined based on an interim analysis of the PK data from Periods 1 and 2.
Palbociclib 125mgDrug
Also called PD-0332991
In Period 1, healthy non-Asian subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects of Japanese Descent | Experimental | Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods. Receives: Drug: Palbociclib 75mg; Drug: Palbociclib 125mg; Drug: Palbociclib 100mg; Drug: Palbociclib |
| Healthy Non-Asian Subjects | Experimental | Enrolled healthy non-Asian subjects will receive a single 125mg oral dose of palbociclib in a single treatment period. Receives: Drug: Palbociclib 125mg |
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: 0-120 hours
Dose-normalised Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - 8)DN= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by dose. It is obtained from AUC (0 - t) plus AUC (t - 8) all divided by the administered dose.
Measured: 0-120 hours
Maximum Observed Plasma Concentration (Cmax)
Measured: 0-120 hours
Dose-Normalised Maximum Observed Plasma Concentration (Cmax)
Measured: 0-120 hours
Secondary outcomes (6)
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: 0-120 hours
Dose-Normalized 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), all divided by the administered dose.
Measured: 0-120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0-120 hours
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0-120 hours
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: 0-120 hours
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: 0-120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 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
- NCT02059330
- Sponsor's protocol ID
- A5481032
- Status last verified
- Jun 2014
- First submitted
- 7 Feb 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study To Investigate The Effect Of Dose And Ethnicity On Palbociclib (PD-0332991) Pharmacokinetics In Japanese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02059330
- Acronym / sponsor ID
- A5481032
- Conditions
- Healthy
- Keywords
- Japanese PK-Bridging Study, dose-proportionality study, Palbociclib, PD-0332991, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Feb 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 the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days between doses. Additionally, this study will investigate the effect of Japanese ethnicity of palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single dose-level between healthy subjects of Japanese descent and approximately fourteen healthy non-Asian subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects of Japanese Descent | Experimental | Drug: Palbociclib 75mg, Drug: Palbociclib 125mg, Drug: Palbociclib 100mg, Drug: PalbociclibEnrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods. |
| Healthy Non-Asian Subjects | Experimental | Drug: Palbociclib 125mgEnrolled healthy non-Asian subjects will receive a single 125mg oral dose of palbociclib in a single treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must be a healthy male or female of non-childbearing potential
- Subjects must have a BMI (Body Mass Index) between 17.5 and 30.5 kg/m2
- To be eligible for the Japanese cohort, subjects must have 4 biological grandparents who are Japanese that were born in Japan
Key exclusion criteria (4 listed)
- Any condition affecting drug absorption (eg gastrectomy, achlorhydria, etc)
- Use of prescription or non-prescription drugs
- A QTc-interval >450msec or a QRS interval >120msec
- Pregnant or breastfeeding females, females of childbearing potential, and males who are unwilling or unable to use an effective method of contraception for the duration of the study and for 90 days after the last dose of palbociclib in the study
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 75mgAlso: PD-0332991In Period 1, Japanese subjects will receive a single oral 75mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. | Drug | Healthy Subjects of Japanese Descent |
| Palbociclib 125mgAlso: PD-0332991In Period 2, Japanese subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. | Drug | Healthy Subjects of Japanese Descent |
| Palbociclib 100mgAlso: PD-0332991In Period 3, Japanese subjects will receive a single oral 100mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. | Drug | Healthy Subjects of Japanese Descent |
| PalbociclibAlso: PD-0332991In Period 4, Japanese subjects will receive a single oral dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. The amount of the dose will be determined based on an interim analysis of the PK data from Periods 1 and 2. | Drug | Healthy Subjects of Japanese Descent |
| Palbociclib 125mgAlso: PD-0332991In Period 1, healthy non-Asian subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. | Drug | Healthy Non-Asian Subjects |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 0-120 hours
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).
Dose-normalised Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 0-120 hours
AUC (0 - 8)DN= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by dose. It is obtained from AUC (0 - t) plus AUC (t - 8) all divided by the administered dose.
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-120 hours
Dose-Normalised Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-120 hours
6 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0-120 hours
Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0-120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-120 hours
Plasma Decay Half-Life (t1/2)
Time frame: 0-120 hours
Apparent Oral Clearance (CL/F)
Time frame: 0-120 hours
Apparent Volume of Distribution (Vz/F)
Time frame: 0-120 hours
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 24 Jun 2014.
- 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 75mg, Palbociclib 125mg and Palbociclib 100mg 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 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 24 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: 0-120 hours). The study lists 4 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 24 Jun 2014.