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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHF 5074 (fed group)

oral tablet, single dose

Group Type EXPERIMENTAL

CHF 5974

Intervention Type DRUG

Drug is administered to subject after consumption of a high fat, high calorie meal

CHF 5074 (fasting group)

oral tablet, single dose

Group Type EXPERIMENTAL

CHF 5074

Intervention Type DRUG

Drug is administered to subject in a fasting state

Interventions

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CHF 5074

Drug is administered to subject in a fasting state

Intervention Type DRUG

CHF 5974

Drug is administered to subject after consumption of a high fat, high calorie meal

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes