CClinicalTrials.gg
CompletedNCT02237742Updated Nov 14, 2018

A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males

A Phase 1 interventional study of PF-06427878 in Healthy, sponsored by Pfizer. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-14.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male subjects between 18-55 years of age
  2. BMI of 17.5-30.5 kg/m2

Exclusion criteria

Exclusion Criteria:

  1. History of drug or alcohol abuse within 2 years of screening
  2. Subjects without suitable veins for multiple venipuncture/cannulation
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    PF-06427878

    Drug: PF-06427878

Interventions

  • DrugPF-06427878

    Intravenous, 100 micrograms, single dose, 30 minute infusion

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5

  2. Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)

    Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5

  4. Plasma Terminal Elimination Half Life (t1/2)

    Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5

  5. Plasma Systemic Clearance (CL)

    Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5

  6. Plasma Volume of Distribution at Steady State (Vss)

    Time frame: Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5

Secondary outcomes

  1. Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)

    Time frame: Day 1 Hr 0 to 12.5

  2. Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)

    Time frame: Day 1 Hr 0 to 12.5

  3. Renal clearance (CLr)

    Time frame: Day 1 Hr 0 to 12.5

07

Study locations

1 site
  • Quotient Clinical Ltd
    Ruddington, Nottingham NG11 6JS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02237742
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 11, 2014
Start date
Nov 2014
Primary completion
Nov 2014
Completion
Dec 2014
Last update
Nov 14, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion