Safety, Pharmacokinetics and Pharmacodynamics Study of Treatment With CHF 5074 in Healthy Young Male Subjects
NCT00954252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2015-02-10
Summary
The purpose of this study is to evaluate the safety and tolerability of single oral doses of CHF 5074 in young healthy male volunteers.
Conditions
Interventions
- DRUG
-
CHF 5074
1x, oral capsule, single dose
- DRUG
-
placebo, oral capsule, single dose
- DRUG
-
CHF 5074
2x, oral capsule, single dose
- DRUG
-
CHF 5074
4x, oral capsule, single dose
- DRUG
-
CHF 5074
8x, oral capsule, single dose
- DRUG
-
CHF 5074
16x, oral capsule, single dose
- DRUG
-
CHF 5074
24x, oral capsule, single dose
Sponsors & Collaborators
-
CERESPIR
lead INDUSTRY
Principal Investigators
-
Joel S Ross, MD, FACP · Iberica Clinical Research Center
Study Design
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2010-05-31
- Completion
- 2010-05-31
Countries
- United States
Study Locations
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