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Completed

NCT Number: NCT01563497

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

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 tablet.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-05089771

Drug

Oral dispersion TS formulation- fasted

Primary outcomes

  1. Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)

    Time frame: days 1-3

  2. AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)

    Time frame: days 1-3

  3. AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)

    Time frame: days 1-3

  4. Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)

    Time frame: days 1-3

  5. t½ = Elimination half life of PF-05089771 (hr)

    Time frame: days 1-3

Secondary outcomes

  1. evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.

    Time frame: days 1-3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2012
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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