Status:
COMPLETED
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
Lead Sponsor:
CERESPIR
Conditions:
Alzheimer's Disease
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.
Eligibility Criteria
Inclusion
- Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
Exclusion
- Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
- Significant allergic conditions that require medical treatment
- Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
- Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01203384
Start Date
September 1 2010
End Date
December 1 2010
Last Update
February 10 2015
Active Locations (1)
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1
Iberica Clinical Research Center
Eatontown, New Jersey, United States, 07724