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, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02237742

Enrollment

Registered

2014-09-11

Start date

2014-11-30

Completion date

2014-12-31

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGPF-06427878

Intravenous, 100 micrograms, single dose, 30 minute infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

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

Design outcomes

Primary

Measure	Time frame
Plasma Volume of Distribution at Steady State (Vss)	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
Maximum Observed Plasma Concentration (Cmax)	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
Plasma Terminal Elimination Half Life (t1/2)	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
Plasma Systemic Clearance (CL)	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
Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)	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
Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf)	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

Measure	Time frame
Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%)	Day 1 Hr 0 to 12.5
Renal clearance (CLr)	Day 1 Hr 0 to 12.5
Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)	Day 1 Hr 0 to 12.5

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026