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):
Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01203384
First received: September 15, 2010
Last updated: November 17, 2011
Last verified: November 2011
  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:


Further study details as provided by Chiesi Pharmaceuticals Inc.:

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
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
Chiesi Pharmaceuticals Inc.
Investigators
Principal Investigator: Magdy L Shenouda, MD Iberica Clinical Research Center
  More Information

No publications provided

Responsible Party: Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01203384     History of Changes
Other Study ID Numbers: CCD-0913-PR-0038
Study First Received: September 15, 2010
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014