A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults
NCT01981486
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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)
- 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
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.
Based on your search, you may also be interested in
- Pittsburgh, Pennsylvania
- Edmonton, Alberta
- Chilliwack, British Columbia
- Coquitlam, British Columbia
- Langley, British Columbia
- North Vancouver, British Columbia
- Penticton, British Columbia
- Winnipeg, Manitoba
- Bathurst, New Brunswick
- Moncton, New Brunswick
- St. John's, Newfoundland and Labrador
- Halifax, Nova Scotia
- Truro, Nova Scotia
- Bolton, Ontario
- Brampton, Ontario
- Corunna, Ontario
- Fort Erie, Ontario
- Hamilton, Ontario
- London, Ontario
- Markham, Ontario
- Mississauga, Ontario
- Newmarket, Ontario
- Niagara Falls, Ontario
- Woodstock, Ontario
- Montague, Prince Edward Island
- Cowansville, Quebec
- Drummondville, Quebec
- Granby, Quebec
- Montreal, Quebec
- Sainte Julie, Quebec
- Sherbrooke, Quebec
- Regina, Saskatchewan
- Mount Pearl,
- Quebec,
- San Francisco, California
- Stamford, Connecticut
- Chicago, Illinois
- Ann Arbor, Michigan
- Springfield, Missouri
- Pittsburgh, Pennsylvania
- Memphis, Tennessee
- Dallas, Texas
- Houston, Texas
- San Antonio, Texas
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 |
| |||
Study Arms ICMJE |
| |||
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 | 0 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |