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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

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.

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

Placebo Comparator

Arm Label

CHF5074 1x

CHF5074 2x

CHF5074 3x

Placebo

Arm Description

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

NCT ID

NCT01203384

First Posted

September 15, 2010

Last Updated

February 9, 2015

Sponsor

CERESPIR

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

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

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