Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
- Registration Number
- NCT01258452
- Lead Sponsor
- CERESPIR
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF 5074 (fed group) CHF 5974 oral tablet, single dose CHF 5074 (fasting group) CHF 5074 oral tablet, single dose
- Primary Outcome Measures
Name Time Method peak CHF 5074 plasma concentration (Cmax) from Day 1 to Day 5 area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96) from Day 1 to Day 5
- Secondary Outcome Measures
Name Time Method the time of occurrence of Cmax (Tmax) from Day 1 to Day 5
Trial Locations
- Locations (1)
Iberica Clinical Research Center
🇺🇸Eatontown, New Jersey, United States