A Study to Further Understand the Effects of SCH 527123 on Tissue

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: Part 1: SCH 527123 100mg once daily for 14 days, oral Part 2: SCH 527123 10mg twice daily or 30mg once daily or 100mg once daily for 5 days, oral (each subject receives all 5 treatments [3 with SCH 527123, 1 with placebo (sugar pill), 1 with prednisone] in a randomised sequence, separated by 7 days) Separate subjects will be used in each part CONDITION: for Chronic Obstructive Pulmonary Disease(COPD) ‐ the dose‐response relationship of effects of SCH 527123 on neutrophils in the oral mucosa in healthy volunteers, as a determinant of neutrophil response while using study drug for Chronic Obstructive Pulmonary Disease(COPD) ‐ the tolerability and safety of 100 mg SCH 527123 in healthy subjects PRIMARY OUTCOME: Part 1: To evaluate the safety and tolerability of 100 mg SCH 527123 when administered orally for 14 days to healthy volunteers. Measured via blood analysis, questionnaires, mointoring of electrocardiography (ECG) and vital signs (temperature, blood pressure, pulse) Part 2: To define the dose‐response relationship of the effects of SCH 527123 on neutrophils in the oral mucosa. Measured via analysis of oral mucosal neutrophils collected from oral rinses. SECONDARY OUTCOME: Part 1: To characterize multiple dose pharmacokinetic profile of 100 mg SCH 527123 in healthy subjects. Measured via blood analysis. Part 2: To explore the effect of SCH 527123 100 mg on peripheral blood neutrophils and to explore the effect of dose regimen on peripheral blood neutrophils and neutrophils in the oral mucosa. Measured via blood analysis and analysis of oral mucosal neutrophils collected from oral rinses. INCLUSION CRITERIA: Part 1: Healthy adult Part 2: Healthy adult, free of moderate or severe oral mucosal disease
Epistemonikos ID: fe57365d2412ccb26adecd5d33b583c3bf2bde2a
First added on: Aug 25, 2024