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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
St. Paul, Minnesota, 55114 United States
Contact
1-800-718-1021
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).

NCT01981499
Pfizer
Terminated
A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults

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A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Migraine
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
April 2014
April 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01981499
B3441009
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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