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Completed

NCT Number: NCT02237742

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical Ltd

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PF-06427878

Drug

Intravenous, 100 micrograms, single dose, 30 minute infusion

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2014
Registry last updated
Nov 14, 2018

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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