Status:
COMPLETED
Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
Lead Sponsor:
CERESPIR
Conditions:
Alzheimer's Disease
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration 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.
- Subject has a body mass index between 18 and 30 kg/m\^2, inclusive.
Exclusion
- Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- Abnormal result 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 :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01258452
Start Date
February 1 2011
End Date
March 1 2011
Last Update
February 10 2015
Active Locations (1)
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1
Iberica Clinical Research Center
Eatontown, New Jersey, United States, 07724