A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

An Open Label, Randomized 3-Way Crossover Single Dose Study To Compare The Pharmacokinetics And Relative Bioavailability Of PF-04191834 Using An Oral Wet-Milled Suspension Formulation Versus An Oral Single Dose Dispersion Formulation Under Fasted Conditions In Healthy Volunteers

This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-04191834; Drug: PF-04191834; Drug: PF-04191834

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
• 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT >ULN. Subjects with total bilirubin >ULN (except those with a documented history of Gilbert's Syndrome). Subjects with AST/ALT/total bilirubin >ULN and <1.5X ULN may be retested once.
• 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;
• Females of childbearing potential.
• Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oral single dose dispersion 100mg; Subjects receive a single dose of PF-04191834 as a dispersion	Drug: PF-04191834; single dose, 100mg, dispersion; Drug: PF-04191834; single dose, 100mg, suspension; Drug: PF-04191834; single dose, 300mg, suspension
Active Comparator: oral wet milled suspension 100mg; Subjects receive a single dose of PF-04191834 as a suspension	Drug: PF-04191834; single dose, 100mg, dispersion; Drug: PF-04191834; single dose, 100mg, suspension; Drug: PF-04191834; single dose, 300mg, suspension
Active Comparator: oral wet milled suspension 300mg; Subjects receive a single dose of PF-04191834 as a suspension	Drug: PF-04191834; single dose, 100mg, dispersion; Drug: PF-04191834; single dose, 100mg, suspension; Drug: PF-04191834; single dose, 300mg, suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of maximum concentration(Tmax) of PF-04191834 in plasma.	3 days
Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834.	3 days
Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834.	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax) for PF-04191834 in plasma.	3 days
Elimination half-life (t1/2) of PF-04191834	3 days
Sheehan suicidality tracking scale (SSTS)	Screening and last Day of Period 3
Number of adverse events in patients as a measure of safety and tolerability.	Throughout the study.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: November 30, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; Phase 1; healthy volunteers; relative bioavailability; suspension; dispersion
• Other Study ID Numbers: B0041012