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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Anylan Center, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]PF-06427878

Drug

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

PF-06427878 10 mg

Drug

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 600 mg

Drug

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

Primary outcomes

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

    Time frame: All Periods;Day 1;0-120min

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. % 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

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

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

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

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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Plasma PK of PF-06427878: AUCinf, as data permit

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

  12. Plasma PK of PF-06427878: Cmax, as data permit

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

  13. Plasma PK of PF-06427878: Tmax, as data permit

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

  14. Plasma PK of PF-06427878: t½, as data permit

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

  15. Plasma PK of PF-06427878: CL, as data permit

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

  16. Plasma PK of PF-06427878: Vss, as data permit

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

  17. Plasma PK of PF-06427878: Vss, as data permit.

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

  18. Plasma PK of PF-06427878: AUCinf, as data permit.

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

  19. Plasma PK of PF-06427878: Cmax, as data permit.

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

  20. Plasma PK of PF-06427878: Tmax, as data permit.

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

  21. Plasma PK of PF-06427878: t½, as data permit.

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

  22. Plasma PK of PF-06427878: CL/F, as data permit.

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 7, 2015
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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