Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000661279
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
5/08/2009
Date last updated
5/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Further Understand the Effects of SCH 527123 on Tissue
Neutrophils
Scientific title
A Study to Further Understand the Effects of SCH 527123 on Tissue Neutrophils in Healthy Adult Volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
for Chronic Obstructive Pulmonary Disease(COPD) - the tolerability and safety of 100 mg SCH 527123 in healthy subjects 243402 0
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 243449 0
Condition category
Condition code
Respiratory 239710 239710 0 0
Chronic obstructive pulmonary disease
Other 239753 239753 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 237040 0
Treatment: Drugs
Comparator / control treatment
Part 1: Placebo (sugar pill) matched to SCH527123 once daily for 14 days, oral

Part 2: Placebo (sugar pill) matched to SCH 527123 once daily for 5 days, oral OR Prednisone 40 mg once daily for 5 days, oral
Control group
Active

Outcomes
Primary outcome [1] 240478 0
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)
Timepoint [1] 240478 0
Part 1: Assessed on Days 1, 2, 3, 5, 7, 10, 13, 17
Primary outcome [2] 240505 0
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.
Timepoint [2] 240505 0
Part 2: Assessed on Days 1-9 of each period
Secondary outcome [1] 257019 0
Part 1: To characterize multiple dose pharmacokinetic profile of 100 mg SCH 527123 in healthy subjects. Measured via blood analysis.
Timepoint [1] 257019 0
Part 1: Assessed on Days 1-2 and 11-18
Secondary outcome [2] 257061 0
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.
Timepoint [2] 257061 0
Part 2: Assessed on Days 1-9 of each period

Eligibility
Key inclusion criteria
Part 1: Healthy adult

Part 2: Healthy adult, free of moderate or severe oral mucosal disease
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237414 0
Commercial sector/Industry
Name [1] 237414 0
Schering-Plough
Country [1] 237414 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
2000 Galloping Hiill Road
Kenilworth, NJ 07033
Country
United States of America
Secondary sponsor category [1] 236911 0
None
Name [1] 236911 0
Address [1] 236911 0
Country [1] 236911 0

Ethics approval
Ethics application status
Approved

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29988 0
Address 29988 0
Country 29988 0
Phone 29988 0
Fax 29988 0
Email 29988 0
Contact person for public queries
Name 13235 0
Ms Sarah Wilson
Address 13235 0
Nucleus Network Limited
Level 5 Burnet Institute
AMREP Precinct
89 Commercial Road
Melbourne, VIC 3004
Country 13235 0
Australia
Phone 13235 0
61 3 9076 8932
Fax 13235 0
Email 13235 0
[email protected]
Contact person for scientific queries
Name 4163 0
Dr Peter Hodsman
Address 4163 0
Nucleus Network Limited
Level 5 Burnet Institute
AMREP Precinct
89 Commercial Road
Melbourne, VIC 3004
Country 4163 0
Australia
Phone 4163 0
61 3 9076 8960
Fax 4163 0
Email 4163 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.