Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PD-0332991
palbociclib
tamoxifen
drug-drug interaction (DDI) study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
measure: Maximum Observed Plasma Concentration (Cmax) of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
measure: Plasma Decay Half-Life (t1/2) of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
measure: Apparent Oral Clearance (CL/F) of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
measure: Apparent Volume of Distribution (Vz/F) of PD-0332991
timeFrame: 0-144 hrs post PD-0332991 dose
measure: Minimum Observed Plasma Trough Concentration (Cmin) of tamoxifen
timeFrame: Days 1, 5, 12, 21, 22, and 28 of Period 2
measure: Minimum Observed Plasma Trough Concentration (Cmin) of 4-hydroxytamoxifen
timeFrame: Days 1, 5, 12, 21, 22, and 28 of Period 2
measure: Minimum Observed Plasma Trough Concentration (Cmin) of N-desmethyltamoxifen
timeFrame: Days 1, 5, 12, 21, 22, and 28 of Period 2
measure: Minimum Observed Plasma Trough Concentration (Cmin) of endoxifen
timeFrame: Days 1, 5, 12, 21, 22, and 28 of Period 2
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: