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
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: PH-797804
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 28
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479647

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01479647     History of Changes
Other Study ID Numbers: A6631034
Study First Received: November 22, 2011
Last Updated: February 25, 2012
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on September 16, 2014