A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01690351
First received: September 10, 2012
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: PF-05089771 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: days 1-2 ] [ Designated as safety issue: No ]
- AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) [ Time Frame: days 1-2 ] [ Designated as safety issue: No ]
- AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: days 1-2 ] [ Designated as safety issue: No ]
- Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: days 1-2 ] [ Designated as safety issue: No ]
- t½ = Elimination half life of PF-05089771 (hr) [ Time Frame: days 1-2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: days 1-2 ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | September 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PF-05089771 Oral Dispersion fasted
Oral dispersion TS formulation- fasted
|
Drug: PF-05089771
Oral dispersion TS formulation- fasted
|
|
Experimental: PF-05089771 TS formulation fasted
Capsules TS formulation- fasted
|
Drug: PF-05089771
Capsules TS formulation- fasted
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years
Exclusion Criteria:
- 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01690351 History of Changes |
| Other Study ID Numbers: | B3291015 |
| Study First Received: | September 10, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | Belgium: Belgian Health Authority |
ClinicalTrials.gov processed this record on June 18, 2013