Alzheimer's Disease
Conditions
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.
Interventions
DRUGCHF 5074
Drug is administered to subject in a fasting state
DRUGCHF 5974
Drug is administered to subject after consumption of a high fat, high calorie meal
Sponsors
CERESPIR
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96) | from Day 1 to Day 5 |
| peak CHF 5074 plasma concentration (Cmax) | from Day 1 to Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| the time of occurrence of Cmax (Tmax) | from Day 1 to Day 5 |
Countries
United States
Outcome results
None listed