A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
April 29, 2012 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female of non-childbearing potential
Exclusion Criteria:
- Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: PF-05180999 Immediate-Release
|
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
|
|
EXPERIMENTAL: PF-05180999 Modified-Release 1
|
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
|
|
EXPERIMENTAL: PF-05180999 Modified-Release 2
|
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
|
|
EXPERIMENTAL: PF-05180999 Modified-Release 1 With Food
|
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
|
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)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
|
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)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
|
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)
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
|
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 - ∞)]
Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
|
0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (ACTUAL)
April 1, 2012
Study Completion (ACTUAL)
April 1, 2012
Study Registration Dates
First Submitted
February 7, 2012
First Submitted That Met QC Criteria
February 7, 2012
First Posted (ESTIMATE)
February 10, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 29, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B3441007
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