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

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called SCH 527123, which may help control inflammation by reducing the number of white blood cells called neutrophils in tissues. Too many neutrophils in tissues can cause or worsen inflammatory conditions like COPD. This trial has two parts: Part 1 tests whether a 100 mg dose is safe in healthy adults over 14 days. Part 2 looks at how different doses of SCH 527123 compare to placebo (inactive pill) and prednisone (a steroid) in reducing neutrophils in the mouth lining. The results may help guide future studies in people with COPD. You may be eligible if: - You are between 18 and 65 years old - You are a healthy adult - You are free of moderate or severe mouth disease (for Part 2) You may NOT be eligible if: - You have a history of cancer - You currently smoke - You have HIV, Hepatitis B, or Hepatitis C - Your neutrophil count is low (below 2.5 x 10⁹/L) Talk to your doctor about whether this trial might be right for you.

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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