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

NCT01247883 — Phase 1, Completed, 13 participants, Pfizer

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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

Registry	NCT01247883
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	13 (Actual)
Sponsor	Pfizer (Industry); collaborators: Incyte Corporation
Conditions	Healthy
Interventions	PF-04634817 (Drug)
Dates	start 2010-10-01, primary completion 2010-12-01, completion 2010-12-01, first posted 2010-11-24, last updated 2011-02-02
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
single dose PF-04634817 tablet	Active comparator	Drug: PF-04634817	subjects receive a single dose of PF-04634817 as a tablet
single dose PF-04634817 solution	Active comparator	Drug: PF-04634817	subjects receive a single dose of PF-04634817 as a solution

PF-04634817 (Drug): single dose, 20mg, tablet
PF-04634817 (Drug): single dose, 20mg, solution

+Outcome measures

Primary outcomes

adverse events [4 days]
Plasma Pharmacokinetics for both tablet and solution dosage forms. [4 days]
The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution. [4 days]
lab measurements [4 days]
vitals/ECG parameters [4 days]

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Pfizer Investigational Site	New Haven, Connecticut	United States

+Investigators

Pfizer CT.gov Call Center, Study director, Pfizer