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Trial record 1 of 50 for:    0332991 and pfizer
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A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01821066
First received: March 26, 2013
Last updated: October 6, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Healthy
Drug: PD-0332991 alone
Drug: Tamoxifen 60 mg
Drug: Tamoxifen 20 mg
Drug: PD-0332991 combination
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

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

  • 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.

  • 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.

  • 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 ]

Enrollment: 25
Study Start Date: April 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Two-Period Fixed-Sequence Arm
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.
Drug: PD-0332991 alone
PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1.
Other Name: PD-0332991, palbociclib
Drug: Tamoxifen 60 mg
On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets).
Drug: Tamoxifen 20 mg
On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses.
Drug: PD-0332991 combination
PD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose.
Other Name: PD-0332991, palbociclib

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821066

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01821066     History of Changes
Other Study ID Numbers: A5481026
Study First Received: March 26, 2013
Last Updated: October 6, 2015

Keywords provided by Pfizer:
PD-0332991
palbociclib
tamoxifen
drug-drug interaction (DDI) study

Additional relevant MeSH terms:
Tamoxifen
Palbociclib
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 28, 2017