Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion
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
1 other identifier
interventional
12
1 country
1
Brief Summary
This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2013
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
May 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 25, 2013
June 1, 2013
1 month
May 8, 2013
June 24, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Number of Participants With Laboratory Test Values of Potential Clinical Importance
48 hours
Study Arms (3)
Oral disperion fasted
EXPERIMENTALA single dose of 450 mg PF-05089771 TS oral dispersion in fasted conditions.
Capsule fasted
EXPERIMENTALsingle dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fasted conditions
Capsule fed
EXPERIMENTALsingle dose of 450 mg PF-05089771 TS as 3 x 150 mg capsules in fed conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2013
First Posted
May 16, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 25, 2013
Record last verified: 2013-06