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

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ClinicalTrials.gov Identifier: NCT01247883
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : February 2, 2011
Sponsor:
Collaborator:
Incyte Corporation
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: PF-04634817 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. adverse events [ Time Frame: 4 days ]
  2. Plasma Pharmacokinetics for both tablet and solution dosage forms. [ Time Frame: 4 days ]
  3. The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution. [ Time Frame: 4 days ]
  4. lab measurements [ Time Frame: 4 days ]
  5. vitals/ECG parameters [ Time Frame: 4 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

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): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01247883     History of Changes
Other Study ID Numbers: B1261005
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: February 2, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Pharmaceutical Solutions