HealthyPhase 1NCT01821066
A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers
A Phase 1 study testing PD-0332991 alone, Tamoxifen 60 mg and Tamoxifen 20 mg in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PD-0332991 alone, Tamoxifen 60 mg and Tamoxifen 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between the ages of 18 and 55 years of age inclusive
- Body mass index (BMI) between 17.5 and 30.5 kg/m2
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- a positive urine drug screen
- a supine systolic blood pressure >140 mm Hg, or diastolic blood pressure >90 mm H.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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 Two-Period Crossover Study Of The Effect Of Multiple Doses Of Tamoxifen On PD-0332991 Pharmacokinetics In Healthy Male Volunteers
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- PD-0332991 alone, Tamoxifen 60 mg, Tamoxifen 20 mg, PD-0332991 combination
- Keywords
- PD-0332991, palbociclib, tamoxifen, drug-drug interaction (DDI) study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-0332991 aloneDrug
Also called PD-0332991, palbociclib
PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1.
Tamoxifen 60 mgDrug
On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets).
Tamoxifen 20 mgDrug
On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses.
PD-0332991 combinationDrug
Also called PD-0332991, palbociclib
PD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose.
| Study group | Role | What they receive |
|---|---|---|
| Two-Period Fixed-Sequence Arm | Experimental | This arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991. Receives: Drug: PD-0332991 alone; Drug: Tamoxifen 60 mg; Drug: Tamoxifen 20 mg; Drug: PD-0332991 combination |
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)] of PD-0332991
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: 0-144 hrs post PD-0332991 dose
Secondary outcomes (10)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 0-144 hrs post PD-0332991 dose
Maximum Observed Plasma Concentration (Cmax) of PD-0332991
Measured: 0-144 hrs post PD-0332991 dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991
Measured: 0-144 hrs post PD-0332991 dose
Plasma Decay Half-Life (t1/2) of PD-0332991
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0-144 hrs post PD-0332991 dose
Apparent Oral Clearance (CL/F) of PD-0332991
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: 0-144 hrs post PD-0332991 dose
Apparent Volume of Distribution (Vz/F) of PD-0332991
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: 0-144 hrs post PD-0332991 dose
Minimum Observed Plasma Trough Concentration (Cmin) of tamoxifen
Measured: Days 1, 5, 12, 21, 22, and 28 of Period 2
Minimum Observed Plasma Trough Concentration (Cmin) of 4-hydroxytamoxifen
Measured: Days 1, 5, 12, 21, 22, and 28 of Period 2
Minimum Observed Plasma Trough Concentration (Cmin) of N-desmethyltamoxifen
Measured: Days 1, 5, 12, 21, 22, and 28 of Period 2
Minimum Observed Plasma Trough Concentration (Cmin) of endoxifen
Measured: Days 1, 5, 12, 21, 22, and 28 of Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionAug 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01821066
- Sponsor's protocol ID
- A5481026
- Status last verified
- Oct 2015
- First submitted
- 26 Mar 2013
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Fixed-Sequence Two-Period Crossover Study Of The Effect Of Multiple Doses Of Tamoxifen On PD-0332991 Pharmacokinetics In Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01821066
- Acronym / sponsor ID
- A5481026
- Conditions
- Healthy
- Keywords
- PD-0332991, palbociclib, tamoxifen, drug-drug interaction (DDI) study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 Mar 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.
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two-Period Fixed-Sequence Arm | Experimental | Drug: PD-0332991 alone, Drug: Tamoxifen 60 mg, Drug: Tamoxifen 20 mg, Drug: PD-0332991 combinationThis arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male between the ages of 18 and 55 years of age inclusive
- Body mass index (BMI) between 17.5 and 30.5 kg/m2
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria (3 listed)
- a positive urine drug screen
- a supine systolic blood pressure >140 mm Hg, or diastolic blood pressure >90 mm H.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
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 |
|---|---|---|
| PD-0332991 aloneAlso: PD-0332991, palbociclibPD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1. | Drug | Two-Period Fixed-Sequence Arm |
| Tamoxifen 60 mgOn Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets). | Drug | Two-Period Fixed-Sequence Arm |
| Tamoxifen 20 mgOn Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses. | Drug | Two-Period Fixed-Sequence Arm |
| PD-0332991 combinationAlso: PD-0332991, palbociclibPD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose. | Drug | Two-Period Fixed-Sequence Arm |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
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).
10 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
Maximum Observed Plasma Concentration (Cmax) of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
Plasma Decay Half-Life (t1/2) of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
Apparent Oral Clearance (CL/F) of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
Apparent Volume of Distribution (Vz/F) of PD-0332991
Time frame: 0-144 hrs post PD-0332991 dose
Minimum Observed Plasma Trough Concentration (Cmin) of tamoxifen
Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2
Minimum Observed Plasma Trough Concentration (Cmin) of 4-hydroxytamoxifen
Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2
Minimum Observed Plasma Trough Concentration (Cmin) of N-desmethyltamoxifen
Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2
Minimum Observed Plasma Trough Concentration (Cmin) of endoxifen
Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2
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 8 Oct 2015.
- 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 PD-0332991 alone, Tamoxifen 60 mg and Tamoxifen 20 mg 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 8 Oct 2015. 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)] of PD-0332991 (time frame: 0-144 hrs post PD-0332991 dose). 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 8 Oct 2015.