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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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NCT02237742

Last updated on March 26, 2020
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FOR MORE INFORMATION
Study Location
Quotient Clinical Ltd
Ruddington, Nottingham, NG11 6JS United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy male subjects between 18-55 years of age

2. BMI of 17.5-30.5 kg/m2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. History of drug or alcohol abuse within 2 years of screening

2. Subjects without suitable veins for multiple venipuncture/cannulation

NCT02237742
Pfizer
Completed
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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Pfizer Clinical Trials Contact Center

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[email protected]

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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 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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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