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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: CHF 5974; Drug: CHF 5074

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Iberica Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)	from Day 1 to Day 5
peak CHF 5074 plasma concentration (Cmax)	from Day 1 to Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
the time of occurrence of Cmax (Tmax)	from Day 1 to Day 5

Collaborators and Investigators

• Sponsor: CERESPIR
• Investigators: Principal Investigator: Magdy L. Shenouda, MD, Iberica Clinical Research Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 13, 2010

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 9, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: CCD-1013-PR-0052