Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-05089771

• Registration Number: NCT01854996
• Lead Sponsor: Pfizer

Brief Summary

This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-24
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy male and/or female subjects 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 and clinical laboratory tests). Females must be of non-childbearing potential.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral disperion fasted	PF-05089771	A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions.
Capsule fasted	PF-05089771	single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions
Capsule fed	PF-05089771	single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)	48 hours

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Laboratory Test Values of Potential Clinical Importance	48 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Brussels, Belgium