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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01247883

Collaborator

Incyte Corporation (Industry)

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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 Drug: PF-04634817	Phase 1

Study Design

Study Type:

Interventional

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 :

Oct 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.