A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)

The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: PH-797804

• 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 subjects and/or healthy female subjects of non-child bearing 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 measurements, 12-lead ECG and 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 time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 14 drinks/week for males.

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

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PH-797804 PARTICLE SIZE 9-11UM	Drug: PH-797804; Tablet, 6 mg, single dose
Experimental: PH-797804 PARTICLE SIZE 9-11UM WITH SLS	Drug: PH-797804; Tablet, 6 mg, single dose
Experimental: PH-797804 PARTICLE SIZE <= 20UM	Drug: PH-797804; Tablet, 6 mg, single dose
Experimental: PH-797804 PARTICLE SIZE <= 20UM WITH SLS	Drug: PH-797804; Tablet, 6 mg, single dose
Experimental: PH-797804 PARTICLE SIZE <= 5UM	Drug: PH-797804; Tablet, 6 mg, single dose
Experimental: PH-797804 PARTICLE SIZE <= 5UM WITH SLS	Drug: PH-797804; Tablet, 6 mg, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Time 72 hours (AUC72)	Area under the plasma concentration time-curve from zero to 72 hours (AUC72)	0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Maximum Observed Plasma Concentration (Cmax)		0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)		0,2,3,4,5,6,8,12,24,48,72 hours post-dose

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: March 1, 2014
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 20, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: A6631040