A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers

NCT01821066 | Completed Phase 1

• 1 other identifier: A5481026
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

PD-0332991; palbociclib; tamoxifen; drug-drug interaction (DDI) study

Outcome Measures

Primary Outcomes (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).

  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

  0-144 hrs post PD-0332991 dose

• Maximum Observed Plasma Concentration (Cmax) of PD-0332991

  0-144 hrs post PD-0332991 dose

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

  0-144 hrs post PD-0332991 dose

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

  0-144 hrs post PD-0332991 dose

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

  0-144 hrs post PD-0332991 dose

Study Arms (1)

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.

Drug: PD-0332991 alone; Drug: Tamoxifen 60 mg; Drug: Tamoxifen 20 mg; Drug: PD-0332991 combination

Interventions

PD-0332991 alone DRUG

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

Also known as: PD-0332991, palbociclib

Two-Period Fixed-Sequence Arm

Tamoxifen 60 mg DRUG

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

Two-Period Fixed-Sequence Arm

Tamoxifen 20 mg DRUG

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

Two-Period Fixed-Sequence Arm

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.

Also known as: PD-0332991, palbociclib

Two-Period Fixed-Sequence Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

palbociclib; Tamoxifen

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

US (1)