- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810758
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691
November 30, 2009 updated by: Pfizer
A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- 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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18-55, inclusive.
- Body Mass Index (BMI) of 18-30 kg/m2; total body weight >50kg (110lbs).
Exclusion Criteria:
- Pregnant or nursing females.
- Females of child-bearing potential.
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening.
- Smoking within the previous 6 months.
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PF-04878691
|
Oral solution, 3mg, twice weekly, 2 weeks
Oral solution, 6mg, twice weekly, 2 weeks
Oral solution, 9mg, twice weekly, 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety and toleration of multiple ascending oral doses of PF-04878691
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691
Time Frame: 3 weeks
|
3 weeks
|
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, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
December 17, 2008
First Submitted That Met QC Criteria
December 17, 2008
First Posted (Estimate)
December 18, 2008
Study Record Updates
Last Update Posted (Estimate)
December 1, 2009
Last Update Submitted That Met QC Criteria
November 30, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1201002
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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