Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects (CT02)

February 9, 2015 updated by: CERESPIR

Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo, oral tablet, multidose
Drug: Placebo
oral tablet, placebo, once a day in the morning for 14 days
Experimental: CHF5074 1x
oral tablet, multidose
Drug: CHF5074 1x
oral tablet, 1x, once a day in the morning for 14 days
Experimental: CHF5074 2x
oral tablet, multidose
Drug: CHF5074 2x
oral tablet, 2x, once a day in the morning for 14 days
Experimental: CHF5074 3x
oral tablet, multidose
Drug: CHF5074 3x
oral tablet, 3x, once a day in the morning for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: from Screening through Day 18
from Screening through Day 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Dose linearity of CHF5074 plasma levels (Cmax)
Time Frame: Day -1 through Day 18
Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Time Frame: Day -1 through Day 18
Day -1 through Day 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CERESPIR

Investigators

  • Principal Investigator: Magdy L Shenouda, MD, Iberica Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 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

Other Study ID Numbers

  • CCD-0913-PR-0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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