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Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects (CT03)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01258452
First received: December 9, 2010
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: CHF 5074
Drug: CHF 5974
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chiesi Pharmaceuticals Inc.:

Primary Outcome Measures:
  • area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96) [ Time Frame: from Day 1 to Day 5 ] [ Designated as safety issue: No ]
  • peak CHF 5074 plasma concentration (Cmax) [ Time Frame: from Day 1 to Day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the time of occurrence of Cmax (Tmax) [ Time Frame: from Day 1 to Day 5 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF 5074 (fed group)
oral tablet, single dose
 Drug: CHF 5974
Drug is administered to subject after consumption of a high fat, high calorie meal
Experimental: CHF 5074 (fasting group)
oral tablet, single dose
 Drug: CHF 5074
Drug is administered to subject in a fasting state

  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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258452

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: NCT01258452     History of Changes
Other Study ID Numbers: CCD-1013-PR-0052
Study First Received: December 9, 2010
Last Updated: May 18, 2012
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 May 21, 2013