Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

Healthy Clinical Trial

Official title:

A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854996
• Other study ID #: B3291020
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2013
• Last updated: June 24, 2013
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-05089771
450mg
• PF-05089771
450mg
• PF-05089771
450mg

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		48 hours	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		48 hours	No
Secondary	Number of Participants With Laboratory Test Values of Potential Clinical Importance		48 hours	No

External Links

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