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A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
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 non-childbearing potential female subjects between the ages of 18
and 55 years

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

- 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.

NCT01563497
Pfizer
Completed
A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State

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A Study Comparing PF-05089771 TS Tablet to PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And Fed State
A Phase 1, Open-Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Tablet To PF-05089771 TS Oral Dispersion In The Fasted State And To PF-05089771 TS Tablet In The Fasted And The Fed State
The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pain
  • Drug: PF-05089771
    Oral dispersion TS formulation- fasted
  • Drug: PF-05089771
    Tablets TS formulation- fasted
  • Drug: PF-05089771
    Tablets TS formulation- fed
  • Experimental: PF-05089771 Oral Dispersion fasted
    Oral dispersion TS formulation- fasted
    Intervention: Drug: PF-05089771
  • Experimental: PF-05089771 TS formulation fasted
    Tablets TS formulation- fasted
    Intervention: Drug: PF-05089771
  • Experimental: PF-05089771 TS formulation fed
    Tablets TS formulation- fed
    Intervention: Drug: PF-05089771
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2012
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01563497
B3291007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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