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

October 20, 2010
January 31, 2011
October 2010
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, and blood and urine safety tests. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • Plasma Pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, t½ 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 ]
Complete list of historical versions of study NCT01247883 on ClinicalTrials.gov Archive Site
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A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: PF-04634817
    single dose, 20mg, tablet
  • Drug: PF-04634817
    single dose, 20mg, solution
  • Active Comparator: single dose PF-04634817 tablet
    subjects receive a single dose of PF-04634817 as a tablet
    Intervention: Drug: PF-04634817
  • Active Comparator: single dose PF-04634817 solution
    subjects receive a single dose of PF-04634817 as a solution
    Intervention: Drug: PF-04634817
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01247883
B1261005
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Incyte Corporation
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP