NCT02237742

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

Same day

First QC Date

September 9, 2014

Last Update Submit

November 12, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

Secondary Outcomes (3)

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

    Day 1 Hr 0 to 12.5

  • 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

Study Arms (1)

PF-06427878

EXPERIMENTAL
Drug: PF-06427878

Interventions

PF-06427878DRUG

Intravenous, 100 micrograms, single dose, 30 minute infusion

PF-06427878

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical Ltd

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 11, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

GB(1)