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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CERESPIR

ClinicalTrials.gov Identifier:

NCT01203384

First received: September 15, 2010

Last updated: February 9, 2015

Last verified: February 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: CHF5074 1x Drug: CHF5074 2x Drug: CHF5074 3x Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

Genetic and Rare Diseases Information Center resources: Alzheimer Disease Familial

U.S. FDA Resources

Further study details as provided by CERESPIR:

Primary Outcome Measures:

Adverse Events [ Time Frame: from Screening through Day 18 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Dose linearity of CHF5074 plasma levels (Cmax) [ Time Frame: Day -1 through Day 18 ] [ Designated as safety issue: No ]
Dose linearity of CHF5074 plasma levels (AUC 0-t) [ Time Frame: Day -1 through Day 18 ] [ Designated as safety issue: No ]


Enrollment:	48
Study Start Date:	September 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CHF5074 1x oral tablet, multidose	Drug: CHF5074 1x oral tablet, 1x, once a day in the morning for 14 days
Experimental: CHF5074 2x oral tablet, multidose	Drug: CHF5074 2x oral tablet, 2x, once a day in the morning for 14 days
Experimental: CHF5074 3x oral tablet, multidose	Drug: CHF5074 3x oral tablet, 3x, once a day in the morning for 14 days
Placebo Comparator: Placebo placebo, oral tablet, multidose	Drug: Placebo oral tablet, placebo, once a day in the morning for 14 days

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203384

Locations


United States, New Jersey
Iberica Clinical Research Center
Eatontown, New Jersey, United States, 07724

Sponsors and Collaborators

CERESPIR

Investigators


Principal Investigator:	Magdy L Shenouda, MD	Iberica Clinical Research Center

More Information

No publications provided


Responsible Party:	CERESPIR
ClinicalTrials.gov Identifier:	NCT01203384 History of Changes
Other Study ID Numbers:	CCD-0913-PR-0038
Study First Received:	September 15, 2010
Last Updated:	February 9, 2015
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:


Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia	Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies

ClinicalTrials.gov processed this record on February 26, 2015

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