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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000661279

Enrollment

Registered

2009-08-05

Start date

2009-07-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

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/L

Outcome results