NCT02410525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

April 2, 2015

Last Update Submit

October 27, 2015

Conditions

Healthy

Keywords

hyperlipidemiapositron emission tomography

Outcome Measures

Primary Outcomes (2)

  • Percent injected radioactivity (per gram) over time in the liver

    All Periods;Day 1;0-120min

  • Percent injected radioactivity (per gram) over time in the 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

Secondary Outcomes (22)

  • Relative radioactivity in liver versus 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

    All Periods;Day 1;0-2hr

  • % of parent in plasma over time

    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

    Period 1;Day 1;0,3,5,15,30,60,90,120,135min

  • Plasma PK of PF-06427878: AUClast, as data permit.

    Periods 2 & 3;Day 1;prebreakfast,-90,-60,0,120min

  • +17 more secondary outcomes

Study Arms (3)

[11C]PF-06427878

EXPERIMENTAL

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

PF-06427878 10 mg

EXPERIMENTAL

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

PF-06427878 600 mg

EXPERIMENTAL

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

Interventions

[11C]PF-06427878DRUG

Single administration via intravenous infusion of 20 ug \[11C\]PF-06427878 on Day 1 of all 3 Periods

[11C]PF-06427878
PF-06427878 10 mgDRUG

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

PF-06427878 10 mg
PF-06427878 600 mgDRUG

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

PF-06427878 600 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Anylan Center

New Haven, Connecticut, 06519, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2015

First Posted

April 7, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

US(3)