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
1-800-254-6398
-
- -A positive urine drug test.
- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG
should be repeated 2 more times and the average of the 3 QTc or QRS values should be
used to determine the subject's eligibility.
- Subjects with family history of myocardial infarction, congenital long QT syndrome,
torsades de pointes or clinically significant ventricular arrhythmias. Subjects should
be within normal range of potassium, magnesium and corrected calcium calculation at
screening.
- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential; male subjects with partners currently pregnant; male subjects
who are unwilling or unable to use two highly effective methods of contraception as
outlined in this protocol for the duration of the study and for at least 90 days after
the last dose of investigational product and, refrain from sperm donation for the
duration of the Study and for at least 90 days after the last dose of investigational
product.
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
- New Haven, Connecticut
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title ICMJE | Glasdegib Absolute Bioavailability Study | ||||
Official Title ICMJE | A Phase One, Single Dose, Randomized, Open-label, Two-period, Two-sequence, Crossover, Absolute Bioavailability Study Of Glasdegib (Pf-04449913) In Healthy Volunteers | ||||
Brief Summary | This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy volunteers. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||
Condition ICMJE | Healthy Volunteer Study | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Shaik N, Hee B, Liang Y, LaBadie RR. Absolute Oral Bioavailability of Glasdegib (PF-04449913), a Smoothened Inhibitor, in Randomized Healthy Volunteers. Clin Pharmacol Drug Dev. 2019 Oct;8(7):895-902. doi: 10.1002/cpdd.692. Epub 2019 Apr 12. | ||||
* 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 | 12 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | October 30, 2017 | ||||
Actual Primary Completion Date | October 6, 2017 (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 | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03270878 | ||||
Other Study ID Numbers ICMJE | B1371022 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
| ||||
PRS Account | Pfizer | ||||
Verification Date | November 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |