A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults

Back to Search
Print
Bookmark Trial

NCT01981486

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

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

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine
Sex
Females and Males
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 and/or female (of non-childbearing potential) subjects between the ages of 18 and 55 years

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

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


- Subjects with Gilbert's disease or 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.


- Subjects with very light skin or very dark skin (at the discretion of the
investigator).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

MigraineProspective Survey of Menstrual Migraine & Prevention With Eletriptan
NCT00259649
  1. Pittsburgh, Pennsylvania
Female
18 Years+
years
MULTIPLE SITES
MigraineA Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults
NCT01981486
ALL GENDERS
18 Years+
years
MULTIPLE SITES
MigraineA Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
NCT00174395
  1. Edmonton, Alberta
  2. Chilliwack, British Columbia
  3. Coquitlam, British Columbia
  4. Langley, British Columbia
  5. North Vancouver, British Columbia
  6. Penticton, British Columbia
  7. Winnipeg, Manitoba
  8. Bathurst, New Brunswick
  9. Moncton, New Brunswick
  10. St. John's, Newfoundland and Labrador
  11. Halifax, Nova Scotia
  12. Truro, Nova Scotia
  13. Bolton, Ontario
  14. Brampton, Ontario
  15. Corunna, Ontario
  16. Fort Erie, Ontario
  17. Hamilton, Ontario
  18. London, Ontario
  19. Markham, Ontario
  20. Mississauga, Ontario
  21. Newmarket, Ontario
  22. Niagara Falls, Ontario
  23. Woodstock, Ontario
  24. Montague, Prince Edward Island
  25. Cowansville, Quebec
  26. Drummondville, Quebec
  27. Granby, Quebec
  28. Montreal, Quebec
  29. Sainte Julie, Quebec
  30. Sherbrooke, Quebec
  31. Regina, Saskatchewan
  32. Mount Pearl,
  33. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
MigraineA Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
NCT00510419
  1. San Francisco, California
  2. Stamford, Connecticut
  3. Chicago, Illinois
  4. Ann Arbor, Michigan
  5. Springfield, Missouri
  6. Pittsburgh, Pennsylvania
  7. Memphis, Tennessee
  8. Dallas, Texas
  9. Houston, Texas
  10. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults
Official Title  ICMJE A Phase I, Placebo Controlled, Randomized, Subject-And Investigator-Blind, Sponsor-Open, Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05180999 In Healthy Adult Volunteers
Brief Summary PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999 administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be evaluated in blood and blister fluid.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Placebo Tablets
    BID modified-release tablets
  • Drug: PF-05180999 Tablets
    BID modified-release tablets (20 to 240 mg BID)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Drug: Placebo Tablets
  • Experimental: PF-05180999
    Modified-release tablets of PF-05180999
    Intervention: Drug: PF-05180999 Tablets
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)		0
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2013)		62
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (of non-childbearing potential) subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Subjects with Gilbert's disease or 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.
  • Subjects with very light skin or very dark skin (at the discretion of the investigator).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981486
Other Study ID Numbers  ICMJE B3441008
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