Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05089771

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854996

B3291020

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Oral disperion fasted

Experimental group

Description:

A single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions.

Treatment:

Drug: PF-05089771

Drug: PF-05089771

Drug: PF-05089771

Capsule fasted

Experimental group

Description:

single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions

Treatment:

Drug: PF-05089771

Drug: PF-05089771

Drug: PF-05089771

Capsule fed

Experimental group

Description:

single dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions

Treatment:

Drug: PF-05089771

Drug: PF-05089771

Drug: PF-05089771