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

Completed · Phase 1

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01258452

Run by

CERESPIR

People needed

12

Starts

2011-02-01

Expected to finish

2011-03-01

Last updated by the study team

2015-02-10

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Iberica Clinical Research Center — Eatontown, New Jersey, United States

Full record on ClinicalTrials.gov

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