A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.
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 Jan 2012
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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 7, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 1, 2012
April 1, 2012
3 months
February 7, 2012
April 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Maximum Observed Plasma Concentration (Cmax)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Plasma Decay Half-Life (t1/2)
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
Study Arms (4)
PF-05180999 Immediate-Release
EXPERIMENTALPF-05180999 Modified-Release 1
EXPERIMENTALPF-05180999 Modified-Release 2
EXPERIMENTALPF-05180999 Modified-Release 1 With Food
EXPERIMENTALInterventions
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Eligibility Criteria
You may qualify if:
- Male or female of non-childbearing potential
You may not qualify if:
- Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Conditions
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
February 7, 2012
First Posted
February 10, 2012
Study Start
January 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 1, 2012
Record last verified: 2012-04