Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and Chronic Obstructive Pulmonary Disease (COPD) Patients (P05567 AM7)
NCT01068145 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2015-03-26
Summary
Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.
Conditions
Interventions
- DRUG
-
SCH 527123
Very low dose SCH 527123, once daily for 7 days
- DRUG
-
SCH 527123
Low dose SCH 527123, once daily for 7 days
- DRUG
-
SCH 527123
Medium dose SCH 527123, once daily for 7 days
- DRUG
-
SCH 527123
High dose SCH 527123, once daily for 7 days
- DRUG
-
Placebo capsules to match SCH 527123, once daily for 7 days
- DRUG
-
SCH 527123
Low dose capsule SCH 527123, once daily for 14 days
- DRUG
-
SCH 527123
Medium dose capsule SCH 527123, once daily for 14 days
- DRUG
-
SCH 527123
High dose capsule SCH 527123, once daily for 14 days
- DRUG
-
Placebo capsules to match SCH 527123, once daily for 14 days
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2011-03-31
- Completion
- 2011-03-31
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