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Trial record 1 of 1 for:    NCT02237742
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A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males

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ClinicalTrials.gov Identifier: NCT02237742
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date November 14, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
  • 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 ]
  • 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 ]
  • Renal clearance (CLr) [ Time Frame: Day 1 Hr 0 to 12.5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: PF-06427878
Intravenous, 100 micrograms, single dose, 30 minute infusion
Study Arms  ICMJE Experimental: PF-06427878
Intervention: Drug: PF-06427878
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2014)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02237742
Other Study ID Numbers  ICMJE B7871004
2014-002626-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP