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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: CHF5074 1x
    • oral tablet, 1x, once a day in the morning for 14 days
  • Drug: CHF5074 2x
    • oral tablet, 2x, once a day in the morning for 14 days
  • Drug: CHF5074 3x
    • oral tablet, 3x, once a day in the morning for 14 days
  • Drug: Placebo
    • oral tablet, placebo, once a day in the morning for 14 days

Arms, Groups and Cohorts

  • Experimental: CHF5074 1x
    • oral tablet, multidose
  • Experimental: CHF5074 2x
    • oral tablet, multidose
  • Experimental: CHF5074 3x
    • oral tablet, multidose
  • Placebo Comparator: Placebo
    • placebo, oral tablet, multidose

Clinical Trial Outcome Measures

Primary Measures

  • Adverse Events
    • Time Frame: from Screening through Day 18

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • CERESPIR
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Magdy L Shenouda, MD, Principal Investigator, Iberica Clinical Research Center

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