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Completed

NCT Number: NCT01821066

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 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

PD-0332991 alone

Drug

PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1.

Other names: PD-0332991, palbociclib

Tamoxifen 60 mg

Drug

On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets).

Tamoxifen 20 mg

Drug

On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses.

PD-0332991 combination

Drug

PD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose.

Other names: PD-0332991, palbociclib

Primary outcomes

  1. 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).

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991

    Time frame: 0-144 hrs post PD-0332991 dose

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

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

    Time frame: 0-144 hrs post PD-0332991 dose

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

    Time frame: 0-144 hrs post PD-0332991 dose

  4. Plasma Decay Half-Life (t1/2) of PD-0332991

    Time frame: 0-144 hrs post PD-0332991 dose

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

  5. Apparent Oral Clearance (CL/F) of PD-0332991

    Time frame: 0-144 hrs post PD-0332991 dose

    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.

  6. Apparent Volume of Distribution (Vz/F) of PD-0332991

    Time frame: 0-144 hrs post PD-0332991 dose

    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.

  7. Minimum Observed Plasma Trough Concentration (Cmin) of tamoxifen

    Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2

  8. Minimum Observed Plasma Trough Concentration (Cmin) of 4-hydroxytamoxifen

    Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2

  9. Minimum Observed Plasma Trough Concentration (Cmin) of N-desmethyltamoxifen

    Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2

  10. Minimum Observed Plasma Trough Concentration (Cmin) of endoxifen

    Time frame: Days 1, 5, 12, 21, 22, and 28 of Period 2

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2013
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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