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

NCT01203384 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-02-10

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • CERESPIR

    lead INDUSTRY

Principal Investigators

  • Magdy L Shenouda, MD · Iberica Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01203384 on ClinicalTrials.gov