Clinical trial NCT02410525: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: hyperlipidemia
positron emission tomography
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent injected radioactivity (per gram) over time in the liver
timeFrame: All Periods;Day 1;0-120min
measure: Percent injected radioactivity (per gram) over time in the plasma
timeFrame: 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 outcomes:
measure: Relative radioactivity in liver versus plasma
timeFrame: 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
measure: Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the gall bladder, if this region is identifiable
timeFrame: All Periods;Day 1;0-2hr
measure: % of parent in plasma over time
timeFrame: 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
measure: Plasma PK of PF-06427878: AUClast, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: AUClast, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
measure: Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the biliary tree, if this region is identifiable
timeFrame: All Periods;Day 1;0-2hr
measure: Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the abdominal fat, if this region is identifiable
timeFrame: All Periods;Day 1;0-2hr
measure: Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the kidney, if this region is identifiable
timeFrame: All Periods;Day 1;0-2hr
measure: Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the urinary bladder, if this region is identifiable
timeFrame: All Periods;Day 1;0-2hr
measure: Time-course of total radioactivity as percentage of injected radioactivity (per gram) in the thigh muscle, if this region is identifiable
timeFrame: All Periods;Day 1;0-2hr
measure: Plasma PK of PF-06427878: AUCinf, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: Cmax, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: Tmax, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: t½, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: CL, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: Vss, as data permit
timeFrame: Period 1;Day 1;0,3,5,15,30,60,90,120,135min
measure: Plasma PK of PF-06427878: Vss, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
measure: Plasma PK of PF-06427878: AUCinf, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
measure: Plasma PK of PF-06427878: Cmax, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
measure: Plasma PK of PF-06427878: Tmax, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
measure: Plasma PK of PF-06427878: t½, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
measure: Plasma PK of PF-06427878: CL/F, as data permit.
timeFrame: Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Anylan Center
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: