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
  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:


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
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: 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 July 20, 2014