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Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects | Clinical Trials | Clareo Health

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

Randomized, Balanced, Single Dose, Cross-Over Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

NCT01258452•CERESPIR

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

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.

Locations (1)

Iberica Clinical Research Center

Eatontown, New Jersey, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

February 10, 2015

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

CHF 5074

DRUG

CHF 5974

DRUG

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RECRUITING

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Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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