- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01499017
A Single Dose Study Of PF-06291874 In Healthy Adult Subjects
January 27, 2012 updated by: Pfizer
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects
The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.
The trial was terminated on Jan 9, 2012, due to undesired pharmacokinetic properties.
The decision to terminate the trial was not based on any safety or efficacy concerns.
Study Type
Interventional
Enrollment (Actual)
9
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
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
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A
Each subjects in Cohort A will receive 3 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-4.
|
PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 3 mg to 100 mg.
Correspondingly, placebo doses will be administered as suspension.
|
Experimental: Cohort B
Each subjects in Cohort B will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.
|
PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 300 mg to 650 mg.
Correspondingly, placebo doses will be administered as suspension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability data: number of subjects with adverse events and Laboratory Test Values of Potential Clinical Importance, Changes from baseline in pulse rate, blood pressure and Electrocardiogram (ECG) measurements over 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) - Fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Maximum Observed Plasma Concentration (Cmax) fasted - 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) -fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Plasma Decay Half-Life (t1/2) fasted 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Apparent Oral Clearance (CL/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
Apparent Volume of Distribution (V/F) fed 0, 0.5, 1,2,3,4,6,8,12,16,24,36 and 48 hrs
Time Frame: 2 days/dose group
|
2 days/dose group
|
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
November 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 14, 2011
First Submitted That Met QC Criteria
December 21, 2011
First Posted (Estimate)
December 26, 2011
Study Record Updates
Last Update Posted (Estimate)
January 31, 2012
Last Update Submitted That Met QC Criteria
January 27, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- B4801001
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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