Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
CT02
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 10, 2015
February 1, 2015
3 months
September 15, 2010
February 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
from Screening through Day 18
Secondary Outcomes (2)
Dose linearity of CHF5074 plasma levels (Cmax)
Day -1 through Day 18
Dose linearity of CHF5074 plasma levels (AUC 0-t)
Day -1 through Day 18
Study Arms (4)
CHF5074 1x
EXPERIMENTALoral tablet, multidose
CHF5074 2x
EXPERIMENTALoral tablet, multidose
CHF5074 3x
EXPERIMENTALoral tablet, multidose
Placebo
PLACEBO COMPARATORplacebo, oral tablet, multidose
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CERESPIRlead
Study Sites (1)
Iberica Clinical Research Center
Eatontown, New Jersey, 07724, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdy L Shenouda, MD
Iberica Clinical Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 10, 2015
Record last verified: 2015-02