Status:
COMPLETED
Multiple Dose Healthy Volunteer Safety Pharmacokinetics Study
Lead Sponsor:
Pfizer
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Multiple dose safety and pharmacokinetics in healthy male subjects
Eligibility Criteria
Inclusion
- Healthy male subjects 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).
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 17.5 kg/m2 may be rounded up to 18.0 kg/m2; a BMI upper limit of 30.5 kg/m2 may be rounded down to 30.0 kg/m2 and will be acceptable for inclusion.
Exclusion
- 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).
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00864786
Start Date
September 1 2008
End Date
March 1 2009
Last Update
March 23 2009
Active Locations (1)
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1
Pfizer Investigational Site
Brussels, Belgium, 1070