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

Recruiting

• Conditions: for Chronic Obstructive Pulmonary Disease(COPD) - the tolerability and safety of 100 mg SCH 527123 in healthy subjects; 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; Respiratory - Chronic obstructive pulmonary disease; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12609000661279
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Part 1: Healthy adult

Part 2: Healthy adult, free of moderate or severe oral mucosal disease

Exclusion Criteria

History of malignancy, subjects who smoke, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Neutrophil count of < 2.5 x 10^9/

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 1: Assessed on Days 1, 2, 3, 5, 7, 10, 13, 17];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.[Part 2: Assessed on Days 1-9 of each period]

Secondary Outcome Measures

Name	Time	Method
Part 1: To characterize multiple dose pharmacokinetic profile of 100 mg SCH 527123 in healthy subjects. Measured via blood analysis.[Part 1: Assessed on Days 1-2 and 11-18];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.[Part 2: Assessed on Days 1-9 of each period]