A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography Scanning

October 27, 2015 updated by: Pfizer

A Phase 1, Open-label, 3-period, Randomized, Partially Fixed Sequence, 2-way Crossover Study With A Microdose Of [11c]Pf-06427878 Administered With And Without Two Non-radioactive Doses Of Pf-06427878 To Characterize Tissue Distribution Using Positron Emission Tomography In Healthy Adult Male Subjects

In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. The study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • New Haven Clinical Research Unit
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
      • New Haven, Connecticut, United States, 06519
        • Anylan Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy males
  • body mass index 17.5-30.5 kg/m2 ; body weight >50 kg
  • signed and dated informed consent document
  • willing and able to comply with study requirements

Exclusion Criteria:

  • tobacco/nicotine containing products > equivalent of 5 cigarettes per day
  • history of cumulative ionizing radiation exposure in the past year, including anticipated exposure in this study, and subjects with current, past or anticipated exposure to radiation in the workplace
  • severe claustrophobia
  • unable to lie still for the required period to acquire images

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [11C]PF-06427878
Single intravenous infusion of [11C]PF-06427878 in Periods 1, 2 and 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability
Drug: [11C]PF-06427878
Single administration via intravenous infusion of 20 ug [11C]PF-06427878 on Day 1 of all 3 Periods
Experimental: PF-06427878 10 mg
Single oral dose of 10 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability
Drug: PF-06427878 10 mg
Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration
Experimental: PF-06427878 600 mg
Single oral dose of 600 mg PF-06427878 in Period 2 or 3 to investigate the liver and plasma radioactivity, radioactivity in organs relative to plasma, pharmacokinetics, and safety and tolerability
Drug: PF-06427878 600 mg
Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent injected radioactivity (per gram) over time in the liver
Time Frame: All Periods;Day 1;0-120min
All Periods;Day 1;0-120min
Percent injected radioactivity (per gram) over time in the plasma
Time Frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative radioactivity in liver versus plasma
Time Frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Ratio of AUC of percent injected radioactivity (per gram) over time in liver to AUC of percent injected radioactivity (per gram) over time in plasma
All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable
Time Frame: All Periods;Day 1;0-2hr
All Periods;Day 1;0-2hr
% of parent in plasma over time
Time Frame: All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Parent is study drug PF-06427878
All Periods;Day 1;0hr,1,2,3,4,5,5.5,6,6.5,7,8,9,10,12,15,20,25,30,40,50,60,75,90,105,120min
Plasma PK of PF-06427878: AUClast, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: AUClast, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the biliary tree, if this region is identifiable
Time Frame: All Periods;Day 1;0-2hr
All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the abdominal fat, if this region is identifiable
Time Frame: All Periods;Day 1;0-2hr
All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the kidney, if this region is identifiable
Time Frame: All Periods;Day 1;0-2hr
All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the urinary bladder, if this region is identifiable
Time Frame: All Periods;Day 1;0-2hr
All Periods;Day 1;0-2hr
Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the thigh muscle, if this region is identifiable
Time Frame: All Periods;Day 1;0-2hr
All Periods;Day 1;0-2hr
Plasma PK of PF-06427878: AUCinf, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Cmax, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Tmax, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: t½, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: CL, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Vss, as data permit
Time Frame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Period 1;Day 1;0,3,5,15,30,60,90,120,135min
Plasma PK of PF-06427878: Vss, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: AUCinf, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: Cmax, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: Tmax, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: t½, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Plasma PK of PF-06427878: CL/F, as data permit.
Time Frame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B7871003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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