A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults

NCT01981499

Last updated date
Study Location
Pfizer Investigational Site
St. Paul, Minnesota, 55114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine
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

- Healthy male subjects between the ages of 18 and 55 years

- No history of clinically-relevant atopic or dermatological disease

- Positive reaction to intradermal injection of histamine

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


- Subjects with screening laboratory test results that deviate from the upper and/or
lower limits of the reference or acceptable range. The exception is that all liver
function tests must not exceed the upper limit of normal.


- Subjects with evidence of, or history of, hepatic disorder, including acute or chronic
hepatitis B or hepatitis C


- Intolerance to intradermal histamine injection.


- Subjects with dark skin (Part B only).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults
Official Title  ICMJE A Phase 1, Placebo-Controlled, Crossover, Subject- And Investigator-Blind, Sponsor-Open Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of A Modified-Release Formulation Of PF-05180999 In Healthy Adult Subjects
Brief Summary PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: PF-05180999
    Ascending single oral doses of 120, 240, and 420 mg modified-release tablets
  • Drug: Placebo
    Placebo tablets
  • Drug: 120 mg MR PF-05180999
    Single 120 mg dose administered as modified release formulation
  • Drug: 360 mg MR PF-05180999
    Single 360 mg dose administered as modified release formulation
  • Drug: 10 mg cetirizine
    Single 10 mg dose of cetirizine
Study Arms  ICMJE
  • Experimental: Arm A1
    Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999
    Intervention: Drug: PF-05180999
  • Placebo Comparator: Arm A2
    Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 relative to placebo
    Intervention: Drug: Placebo
  • Experimental: Arm B1
    Part B of study to assess effects of PF-05180999 on histamine-induced wheal
    Intervention: Drug: 120 mg MR PF-05180999
  • Experimental: Arm B2
    Part B of study to assess effects of PF-05180999 on histamine-induced wheal
    Intervention: Drug: 360 mg MR PF-05180999
  • Experimental: Arm B3
    Positive control to ensure histamine-induced wheal assay integrity
    Intervention: Drug: 10 mg cetirizine
  • Experimental: Arm B4
    Placebo control
    Intervention: Drug: Placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 6, 2014)
31
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2013)
33
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years
  • No history of clinically-relevant atopic or dermatological disease
  • Positive reaction to intradermal injection of histamine

Exclusion Criteria:

  • Subjects with screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.
  • Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C
  • Intolerance to intradermal histamine injection.
  • Subjects with dark skin (Part B only).
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 States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981499
Other Study ID Numbers  ICMJE B3441009
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 CenterPfizer
PRS Account Pfizer
Verification Date May 2014

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