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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01479647
Collaborator
(none)
28
Enrollment
1
Location
5
Arms
2
Duration (Months)
13.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Dec 1, 2011
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics: peak plasma concentration [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 [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 [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 [0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Singapore Singapore 188770

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01479647
Other Study ID Numbers:
  • A6631034
First Posted:
Nov 24, 2011
Last Update Posted:
Feb 28, 2012
Last Verified:
Feb 1, 2012

Study Results

No Results Posted as of Feb 28, 2012