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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01203384
First Posted: September 16, 2010
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CERESPIR
  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
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

Resource links provided by NLM:


Further study details as provided by CERESPIR:

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

Responsible Party: CERESPIR
ClinicalTrials.gov Identifier: NCT01203384     History of Changes
Other Study ID Numbers: CCD-0913-PR-0038
First Submitted: September 15, 2010
First Posted: September 16, 2010
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