Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects (CT02)

CereSpir

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: CHF5074 2x; Drug: CHF5074 1x; Drug: CHF5074 3x

Study type: Interventional

Funder types: Industry

Identifiers

NCT01203384

CCD-0913-PR-0038

Details and patient eligibility

About

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.

Enrollment: 48 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups, including a placebo group

CHF5074 1x

Experimental group

Description:

oral tablet, multidose

Treatment:

Drug: CHF5074 1x

CHF5074 2x

Experimental group

Description:

oral tablet, multidose

Treatment:

Drug: CHF5074 2x

CHF5074 3x

Experimental group

Description:

oral tablet, multidose

Treatment:

Drug: CHF5074 3x

Placebo

Placebo Comparator group

Description:

placebo, oral tablet, multidose

Treatment:

Drug: Placebo