Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects (CT02)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CHF5074 1x
CHF5074 2x
CHF5074 3x
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
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.
Exclusion Criteria:
- Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- Abnormal results 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 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
CHF5074 1x
CHF5074 2x
CHF5074 3x
Placebo
Arm Description
oral tablet, multidose
oral tablet, multidose
oral tablet, multidose
placebo, oral tablet, multidose
Outcomes
Primary Outcome Measures
Adverse Events
Secondary Outcome Measures
Dose linearity of CHF5074 plasma levels (Cmax)
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01203384
Brief Title
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
Acronym
CT02
Official Title
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CERESPIR
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHF5074 1x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
CHF5074 2x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
CHF5074 3x
Arm Type
Experimental
Arm Description
oral tablet, multidose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, oral tablet, multidose
Intervention Type
Drug
Intervention Name(s)
CHF5074 1x
Intervention Description
oral tablet, 1x, once a day in the morning for 14 days
Intervention Type
Drug
Intervention Name(s)
CHF5074 2x
Intervention Description
oral tablet, 2x, once a day in the morning for 14 days
Intervention Type
Drug
Intervention Name(s)
CHF5074 3x
Intervention Description
oral tablet, 3x, once a day in the morning for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet, placebo, once a day in the morning for 14 days
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
from Screening through Day 18
Secondary Outcome Measure Information:
Title
Dose linearity of CHF5074 plasma levels (Cmax)
Time Frame
Day -1 through Day 18
Title
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Time Frame
Day -1 through Day 18
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.
Exclusion Criteria:
Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
Abnormal results 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 Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
We'll reach out to this number within 24 hrs