A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Incyte Corporation
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01247883
First received: October 20, 2010
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.


Condition Intervention Phase
Healthy
Drug: PF-04634817
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Two Period, 2 Sequence Crossover To Establish The Relative Bioavailability Of A Single Pf-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • adverse events [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • Plasma Pharmacokinetics for both tablet and solution dosage forms. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • lab measurements [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • vitals/ECG parameters [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: single dose PF-04634817 tablet
subjects receive a single dose of PF-04634817 as a tablet
Drug: PF-04634817
single dose, 20mg, tablet
Active Comparator: single dose PF-04634817 solution
subjects receive a single dose of PF-04634817 as a solution
Drug: PF-04634817
single dose, 20mg, solution

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
  • 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;
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
  • Nursing females;
  • Females of childbearing potential.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247883

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Incyte Corporation
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01247883     History of Changes
Other Study ID Numbers: B1261005
Study First Received: October 20, 2010
Last Updated: January 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
relative bioavailability
healthy volunteers
pharmacokinetics
solution
tablet

ClinicalTrials.gov processed this record on April 15, 2014