Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects (CT03)

CereSpir

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: CHF 5974

Drug: CHF 5074

Study type

Interventional

Funder types

Industry

Identifiers

NCT01258452

CCD-1013-PR-0052

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.