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HealthyPhase 1NCT01756768

A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

A Phase 1 study testing [14C]-PD-0332991 in people with Healthy, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991. 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?
[14C]-PD-0332991
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jan 2013to Mar 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

  • A Healthy Male Volunteer between 18 and 55 years of age inclusive
  • A Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50kg
  • A signed informed consent document

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular,hepatic,psychiatric, neurologic, or allergic disease.
  • A positive urine drug or urine cotinine screen.
  • Concurrent use of herbal or prescription medications or treatment with an investigational drug within 30 days or 5 half-lives preceding first dose of study medication.
  • Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
  • Subjects with a history of irregular bowel movements (eg, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer Investigational Site

    Tacoma, Washington, 98418

Other trials in United States

About this study

Official title: A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] PD-0332991 In Healthy Male Volunteers

This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately 100 microcuries of [14C]-PD-0332991. Subjects will be checked in to the research unit from approximately 12 hours prior to dosing and remain in house until greater than 90% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta on consecutive days. This study will investigate the extent of involvement of the renal and hepatic systems in the elimination of PD-0332991 and will seek to identify the compound's major metabolites.

Conditions
Healthy
Being tested
[14C]-PD-0332991
Keywords
Phase 1, Mass Balance study, Radio-labeled dose, PD-0332991

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-PD-0332991Radiation

    A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of [14C]-PD-0332991.

Study groups in NCT01756768
Study groupRoleWhat they receive
Radio-labeled Dose ArmExperimentalNot described
Receives: Radiation: [14C]-PD-0332991

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 0-192 hrs

  2. 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: 0-192hrs

  3. Maximum Observed Plasma Concentration (Cmax) of PD-0332991

    Measured: 1-24hrs

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991

    Measured: 1-24hrs

  5. 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: 0-192hrs

  6. 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: 0-192hrs

  7. 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: 0-192hrs

  8. Cumulative radioactivity recovery in urine.

    Cumulative radioactivity recovered in urine is the percent of the administered radioactive dose that is observed in the cumulative urine samples.

    Measured: 0-192hrs

  9. Cumulative radioactivity recovery in feces.

    Cumulative radioactivity recovered in fecal is the percent of the administered radioactive dose that is observed in the cumulative fecal samples.

    Measured: 0-192hrs

Secondary outcomes (12)

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PF-05089326.

    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: 0-192hrs

  2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089326.

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: 0-192hrs

  3. Maximum Observed Plasma Concentration (Cmax) of PF-05089326.

    Measured: 0-192hrs

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089326.

    Measured: 0-192hrs

  5. Plasma Decay Half-Life (t1/2) of PF-05089326.

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: 0-192hrs

  6. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of radioactivity in plasma.

    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: 0-192hrs

  7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of radioactivity in plasma.

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

    Measured: 0-192hrs

  8. Maximum Observed Concentration (Cmax) of radioactivity in plasma.

    Measured: 0-192hrs

  9. Time to Reach Maximum Observed Concentration (Tmax) of radioactivity in plasma.

    Measured: 0-192hrs

  10. Plasma Decay Half-Life (t1/2) of radioactivity in plasma.

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

    Measured: 0-192hrs

  11. Apparent Oral Clearance (CL/F) of radioactivity in plasma.

    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: 0-192hrs

  12. Apparent Volume of Distribution (Vz/F) of radioactivity in plasma.

    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: 0-192 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01756768
Sponsor's protocol ID
A5481011
Status last verified
Dec 2013
First submitted
20 Dec 2012
Last updated
17 Dec 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-PD-0332991 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 5 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 17 Dec 2013. 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: 0-192 hrs). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01756768.

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 17 Dec 2013.

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