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

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ClinicalTrials.gov Identifier: NCT01203384
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
CERESPIR

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CHF5074 1x Drug: CHF5074 2x Drug: CHF5074 3x Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: from Screening through Day 18 ]

Secondary Outcome Measures :
  1. Dose linearity of CHF5074 plasma levels (Cmax) [ Time Frame: Day -1 through Day 18 ]
  2. Dose linearity of CHF5074 plasma levels (AUC 0-t) [ Time Frame: Day -1 through Day 18 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: CERESPIR
ClinicalTrials.gov Identifier: NCT01203384     History of Changes
Other Study ID Numbers: CCD-0913-PR-0038
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders