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To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01064804
First received: September 1, 2009
Last updated: February 5, 2010
Last verified: February 2010
History of Changes

September 1, 2009
February 5, 2010
September 2009
November 2009   (final data collection date for primary outcome measure)
pharmacokinetic parameters of PF-04191834 [ Time Frame: hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01064804 on ClinicalTrials.gov Archive Site
maximum concentration [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
To Test The Relative Bioavailability Of PF-04191834 When Dosed As An Immediate Release Tablet Compared With Solution Following Single And Multiple Dosing
An Open Randomised 4-Way Crossover Single Dose And A Parallel Group Multiple Dose Comparative Pharmacokinetic Study Of The PF-04191834 Phase 2 Tablet And The Phase 1 Dispersion Formulations.

To test the relative bioavailability of PF-04191834 when dosed as an Immediate Release tablet compared with solution following single and multiple dosing.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, plasma, urine, saliva
Non-Probability Sample

young, healthy male volunteers
Asthma
Drug: PF-04191834
PF-04191834. 100mg Immediate Release Tablets or oral suspension
relative bioavailability
Intervention: Drug: PF-04191834
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of approximately 17.5 kg/m2 to 30.5 kg/m2 and a total body weight > 50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Subjects who have urinary LTE4 levels greater than or equal to 30 pg/mg Creatinine at screening following spot urinary collection for Cohort 2.

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.
Male
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01064804
B0041005
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP