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Trial record 2 of 7 for:    CHF5074

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

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ClinicalTrials.gov Identifier: NCT01258452
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: CHF 5074 Drug: CHF 5974 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : February 2011
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. peak CHF 5074 plasma concentration (Cmax) [ Time Frame: from Day 1 to Day 5 ]

Secondary Outcome Measures :
  1. the time of occurrence of Cmax (Tmax) [ Time Frame: from Day 1 to Day 5 ]

Eligibility Criteria

Information from the National Library of Medicine

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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.
  • 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

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): NCT01258452


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: NCT01258452     History of Changes
Other Study ID Numbers: CCD-1013-PR-0052
First Posted: December 13, 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