RecruitingACTRN12609000661279

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

A Study to Further Understand the Effects of SCH 527123 on Tissue Neutrophils in Healthy Adult Volunteers

Sponsor

Schering-Plough

Enrollment

23 participants

Start Date

Jul 19, 2009

Study Type

Interventional

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

Summary

The primary purpose of Part 1 of this study is to determine the safety and tolerability of 100 mg SCH 527123 when dosed for 14 days in healthy adult subjects. The information from this part will provide evidence for/against using 100 mg SCH 527123 in future trials that may involve patients (ie, COPD subjects) The primary purpose of Part 2 of this study is to determine the dose-response relationship between doses of SCH 527123 and compared with inactive treatment (placebo, sugar pill) and active treatment (prednisone). The information from this trial will be used to compare the oral mucosal neutrophil response between SCH 527123 with active (prednisone) and inactive (placebo) treatment.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria2

Part 1: Healthy adult
Part 2: Healthy adult, free of moderate or severe oral mucosal disease

Exclusion Criteria1

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

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Interventions

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

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

Locations(1)

Australia

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ACTRN12609000661279