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Trial registered on ANZCTR


Registration number
ACTRN12609000218291
Ethics application status
Approved
Date submitted
27/03/2009
Date registered
30/04/2009
Date last updated
11/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of Race/Ethnic Origin on the breakdown/elimination of SCH 527123 in the body.
Scientific title
Influence of Race/Ethnic Origin on the Pharmacokinetics of SCH 527123 (in Healthy Volunteers).
Secondary ID [1] 283755 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The Influence of race and ethnic origin on the pharmacokinetics of SCH 527123. 4534 0
Condition category
Condition code
Other 4822 4822 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 10mg, 30mg, 50mg single oral dose on Day 1 (Each subject receives all 3 doses in a randomised sequence, separated by at least 7 days before progressing to part 2 of the study).
Part 2: SCH 527123 10mg or 50mg daily for 7 days (Randomised to receive one or the other dose level)
Intervention code [1] 4293 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5682 0
To determine the influence of race and ethnic origin on the pharmacokinetics of SCH 527123.
(Assessed through comparison of pharmacokinetic (PK) data from blood samples between Japanese, Chinese and Caucasian subjects)
Timepoint [1] 5682 0
Assessed on Days 1-4 for each period of Part 1 of the study and on Days 1 & 6-10 in Part 2 of the study.
Secondary outcome [1] 241581 0
To evaluate the pharmacodynamics, safety & tolerability of SCH 527123 in Healthy Subjects. (Assessed via peripheral blood neutrophil counts and Flourescence-Activated Cell Sorter (FACS) analysis & routine laboratory safety tests (haematology/chemistry & urinalysis)).
Timepoint [1] 241581 0
Assessed throughout the study at Days 1-4 for each period of Part 1 and Days 1& 6-10 for Part 2.

Eligibility
Key inclusion criteria
Parts 1 & 2
- Male/Female Healthy volunteers (must be Caucasian, Japanese or Chinese)
- Caucasian & Chinese volunteers must match Japanese volunteers for sex, age, height, weight, Body Mass Index (BMI) within specified ranges.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Neutrophil count of <2 x 10 9.

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)
Open Label Study. Eligible Japanese subjects assigned a allocation number sequentially. Caucasian and Chinese subjects matched to Japanese subjects by age, weight, height, gender & BMI and allocated to a corresponding allocation number with the same treatment sequence.
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 4725 0
Commercial sector/Industry
Name [1] 4725 0
Schering-Plough
Address [1] 4725 0
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
Country [1] 4725 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough
Address
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
Country
United States of America
Secondary sponsor category [1] 4270 0
None
Name [1] 4270 0
Address [1] 4270 0
Country [1] 4270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6768 0
Ethics committee address [1] 6768 0
Ethics committee country [1] 6768 0
Date submitted for ethics approval [1] 6768 0
27/02/2009
Approval date [1] 6768 0
Ethics approval number [1] 6768 0

Summary
Brief summary
Demographic variables such as age, sex, race and body weight as well as genetic, environmental and cultural factors (eg, diet) may influence the safety & therapeutic response to drugs. Therefore, this study aims to investigate these differences in Japanese, Chinese and Caucasian subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29442 0
A/Prof Peter Hodsman
Address 29442 0
Centre For Clinical Studies 5th Floor Burnet Tower AMREP Precinct 89 Commercial Road Melbourne, VIC 3004
Country 29442 0
Australia
Phone 29442 0
+61 3 9076 8960
Fax 29442 0
Email 29442 0
p.hodsman@nucleusnetwork.com.au
Contact person for public queries
Name 12689 0
Ms Mary Franich
Address 12689 0
Centre For Clinical Studies
5th Floor Burnet Tower
AMREP Precinct
89 Commercial Road
Melbourne, VIC 3004
Country 12689 0
Australia
Phone 12689 0
1800 243 733
Fax 12689 0
Email 12689 0
m.franich@nucleusnetwork.com.au
Contact person for scientific queries
Name 3617 0
A/Prof Peter Hodsman
Address 3617 0
Centre For Clinical Studies
5th Floor Burnet Tower
AMREP Precinct
89 Commercial Road
Melbourne, VIC 3004
Country 3617 0
Australia
Phone 3617 0
+61 3 9076 8960
Fax 3617 0
Email 3617 0
p.hodsman@nucleusnetwork.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary