- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351129
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers
July 5, 2011 updated by: Pfizer
A Phase 1, Single-Dose, Open-Label, Crossover Study To Estimate The Relative Bioavailability Of Two Controlled-Release Formulations Vs. An Immediate Release Formulation Of PF-04991532 In Healthy Adult Subjects
The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.
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
-
-
-
Singapore, Singapore, 188770
- Pfizer Investigational Site
-
-
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
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
- 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.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Formulation 3
|
150-mg modified release capsule, long duration (single dose)
|
Experimental: Formulation 1
|
150-mg immediate release tablet (single dose)
|
Experimental: Formulation 2
|
150-mg modified release capsule, short duration (single dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration versus time profile (AUC)
Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
|
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Max observed plasma concentration (Cmax)
Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
|
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
|
Time of Cmax (Tmax)
Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
|
predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
|
Concentration at 24 hours postdose (C24hr)
Time Frame: 24 hrs postdose
|
24 hrs postdose
|
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
May 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
May 9, 2011
First Submitted That Met QC Criteria
May 9, 2011
First Posted (Estimate)
May 10, 2011
Study Record Updates
Last Update Posted (Estimate)
July 6, 2011
Last Update Submitted That Met QC Criteria
July 5, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B2611009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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