Alzheimer's Disease
Conditions
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.
Interventions
DRUGCHF5074 1x
oral tablet, 1x, once a day in the morning for 14 days
DRUGCHF5074 2x
oral tablet, 2x, once a day in the morning for 14 days
DRUGCHF5074 3x
oral tablet, 3x, once a day in the morning for 14 days
DRUGPlacebo
oral tablet, placebo, once a day in the morning for 14 days
Sponsors
CERESPIR
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | from Screening through Day 18 |
Secondary
| Measure | Time frame |
|---|---|
| Dose linearity of CHF5074 plasma levels (Cmax) | Day -1 through Day 18 |
| Dose linearity of CHF5074 plasma levels (AUC 0-t) | Day -1 through Day 18 |
Countries
United States
Outcome results
None listed