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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CHF 5074
CHF 5974
Sponsored by
CERESPIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Iberica Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CHF 5074 (fed group)

CHF 5074 (fasting group)

Arm Description

oral tablet, single dose

oral tablet, single dose

Outcomes

Primary Outcome Measures

area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)
peak CHF 5074 plasma concentration (Cmax)

Secondary Outcome Measures

the time of occurrence of Cmax (Tmax)

Full Information

First Posted
December 9, 2010
Last Updated
February 9, 2015
Sponsor
CERESPIR
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1. Study Identification

Unique Protocol Identification Number
NCT01258452
Brief Title
Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
Acronym
CT03
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CERESPIR

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5074 (fed group)
Arm Type
Experimental
Arm Description
oral tablet, single dose
Arm Title
CHF 5074 (fasting group)
Arm Type
Experimental
Arm Description
oral tablet, single dose
Intervention Type
Drug
Intervention Name(s)
CHF 5074
Intervention Description
Drug is administered to subject in a fasting state
Intervention Type
Drug
Intervention Name(s)
CHF 5974
Intervention Description
Drug is administered to subject after consumption of a high fat, high calorie meal
Primary Outcome Measure Information:
Title
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
Title
peak CHF 5074 plasma concentration (Cmax)
Time Frame
from Day 1 to Day 5
Secondary Outcome Measure Information:
Title
the time of occurrence of Cmax (Tmax)
Time Frame
from Day 1 to Day 5

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy L. Shenouda, MD
Organizational Affiliation
Iberica Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iberica Clinical Research Center
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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