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

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ClinicalTrials.gov Identifier: NCT01479647
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PH-797804 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : December 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: PH-797804 1 mg Fasted
Subjects will receive a single 1 mg dose in the fasted state
Drug: PH-797804
Tablet, 1 mg, single dose
Experimental: PH-797804 1 mg Fed
Subjects will receive a single 1 mg dose following a high-fat meal
Drug: PH-797804
Tablet, 1 mg, single dose
Experimental: PH-797804 10 mg Fasted
Subjects will receive a single 10 mg dose in the fasted state
Drug: PH-797804
Tablet, 10 mg, single dose
Experimental: PH-797804 10 mg Fed
Subjects will receive a single 10 mg dose following a high-fat meal
Drug: PH-797804
Tablet, 10 mg, single dose
Experimental: PH-797804 24 mg Fed
Subjects will receive a single 24 mg dose following a high-fat meal
Drug: PH-797804
Tablet, 24 mg, single dose



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479647


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01479647     History of Changes
Other Study ID Numbers: A6631034
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012