A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State
NCT01690351
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years
- Evidence or history of clinically significant hematological, renal,endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of
beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Treatment with an investigational drug within 60 days (or as determined by the local
requirement, whichever is longer) or 5 half-lives preceding the first dose of study
medication.
- Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a
single measurement (confirmed by a single repeat, if necessary) following at least 5
minutes of rest 7. Single 12-lead ECG demonstrating QTc >450 msec or a QRS interval
>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds >120 mseca the ECG
should be repeated two more times and the average of the three QTc or QRS values
should be used to determine the subject's eligibility.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State | |||
Official Title ICMJE | A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule | |||
Brief Summary | The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule. | |||
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: Treatment | |||
Condition ICMJE | Pain | |||
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 | Completed | |||
Actual Enrollment ICMJE | 12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2012 | |||
Actual Primary Completion Date | September 2012 (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 | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01690351 | |||
Other Study ID Numbers ICMJE | B3291015 | |||
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 | December 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |