Status:
TERMINATED
Multiple Dose Study in Healthy Volunteers to Assess Safety, Pharmacokinetics and Pharmacodynamics of PF 03882845
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.
Detailed Description
The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.
Eligibility Criteria
Inclusion
- Healthy male and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
- An informed consent document signed and dated by the subject or a legally acceptable representative.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion
- Evidence or history of clinically significant disease, allergy or clinical findings at screening.
- A positive urine drug screen, history of significant regular alcohol consumption within 6 months of screening or use of tobacco or nicotine containing products within the three months preceding study date or a positive urine cotinine at screening or Day -3.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- Pregnant or nursing females; females of childbearing potential.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00856258
Start Date
March 1 2009
End Date
June 1 2009
Last Update
December 23 2009
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511