Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01203384

Run by

CERESPIR

People needed

48

Starts

2010-09-01

Expected to finish

2010-12-01

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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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