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
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: 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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014