HealthyPhase 1NCT02131298
Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib
A Phase 1 study testing Palbociclib Alone and Palbociclib plus itraconazole in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib. 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 plus itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 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 of 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject 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 diseases.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen or alcohol breath test.
- Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
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, Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Single Dose Pharmacokinetics of Palbociclib (PD-0332991) In Healthy Volunteers
This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.
- Conditions
- Healthy
- Being tested
- Palbociclib Alone, Palbociclib plus itraconazole
- Keywords
- Palbociclib, Itraconazole, Pharmacokinetics, Drug-Drug Interaction Study, Healthy Volunteers
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
A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection
Palbociclib plus itraconazoleDrug
Also called Palbociclib (PD-0332991); Itraconazole (Sporanox)
Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.
| Study group | Role | What they receive |
|---|---|---|
| Fixed sequence | Other | Fixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole) Receives: Drug: Palbociclib Alone; Drug: Palbociclib plus itraconazole |
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 to 168 hours
Maximum Observed Plasma Concentration (Cmax)
Measured: 0 to 168 hours
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: 0 to 168 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0 to 168 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 to 168 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 to 168 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 to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02131298
- Sponsor's protocol ID
- A5481016
- Status last verified
- Jun 2014
- First submitted
- 2 May 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence 2-Period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Single Dose Pharmacokinetics of Palbociclib (PD-0332991) In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02131298
- Acronym / sponsor ID
- A5481016
- Conditions
- Healthy
- Keywords
- Palbociclib, Itraconazole, Pharmacokinetics, Drug-Drug Interaction Study, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 May 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 is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.
Study design
- Primary purpose
- Basic science
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fixed sequence | Other | Drug: Palbociclib Alone, Drug: Palbociclib plus itraconazoleFixed sequence study with treatment A of palbociclib alone, followed by treatment B (palbociclib with itraconazole) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- Body mass index of 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject 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 (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases.
- Any condition possibly affecting drug absorption.
- A positive urine drug screen or alcohol breath test.
- Pregnant female subjects; breast feeding female subjects, female subjects of childbearing potential, male subjects with partners currently pregnant, male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.
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-0332991A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection | Drug | Fixed sequence |
| Palbociclib plus itraconazoleAlso: Palbociclib (PD-0332991); Itraconazole (Sporanox)Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection. | Drug | Fixed sequence |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 0 to 168 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).
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 to 168 hours
5 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0 to 168 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0 to 168 hours
Plasma Decay Half-Life (t1/2)
Time frame: 0 to 168 hours
Apparent Oral Clearance (CL/F)
Time frame: 0 to 168 hours
Apparent Volume of Distribution (Vz/F)
Time frame: 0 to 168 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 30 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 Alone and Palbociclib plus itraconazole 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 4 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 30 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 to 168 hours). 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 30 Jun 2014.