A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01479647
First received: November 22, 2011
Last updated: February 25, 2012
Last verified: February 2012

November 22, 2011
February 25, 2012
December 2011
February 2012   (final data collection date for primary outcome measure)
  • Pharmacokinetics: peak plasma concentration [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: time to peak plasma concentration [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the plasma concentration-time curve [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: terminal plasma half-life [ Time Frame: 0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: peak plasma concentration [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: time to peak plasma concentration [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: area under the plasma concentration-time curve [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics: terminal plasma half-life [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01479647 on ClinicalTrials.gov Archive Site
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A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804
A Phase 1, Randomized, Open-Label, Single Dose, 2-Cohort Crossover Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered PH-797804 In Healthy Volunteers

The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: PH-797804
    Tablet, 1 mg, single dose
  • Drug: PH-797804
    Tablet, 10 mg, single dose
  • Drug: PH-797804
    Tablet, 24 mg, single dose
  • Experimental: PH-797804 1 mg Fasted
    Subjects will receive a single 1 mg dose in the fasted state
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 1 mg Fed
    Subjects will receive a single 1 mg dose following a high-fat meal
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 10 mg Fasted
    Subjects will receive a single 10 mg dose in the fasted state
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 10 mg Fed
    Subjects will receive a single 10 mg dose following a high-fat meal
    Intervention: Drug: PH-797804
  • Experimental: PH-797804 24 mg Fed
    Subjects will receive a single 24 mg dose following a high-fat meal
    Intervention: Drug: PH-797804
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 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 measurements, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

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).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week for males.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01479647
A6631034
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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