Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000568910
Ethics application status
Not yet submitted
Date submitted
26/05/2011
Date registered
2/06/2011
Date last updated
2/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics SCH 900931 in Healthy Adult Japanese Subjects.
Scientific title
A Single and Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics SCH 900931 in Healthy Adult Japanese Subjects.
Secondary ID [1] 262261 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers 267959 0
Condition category
Condition code
Other 268096 268096 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mode of Administration will be oral capsule.

Part 1- Cohort 1: Rising single dose SCH900931 (Period 1:20mg, Period 2:100mg & Period 3:550mg).
The duration of each Period will be 6 days, in between doses for Part 1 will be at least 7 days between Period 1 and Period 2 and at least 21 days between Period 2 and Period 3.
Part 2- Cohort 2 & 3 : Rising multiple dose SCH900931 of 2 cohort in a parallel study design (Cohort 2: 150mg & Cohort 3:250mg).
For Part 2, dosing will be once daily for 14 consecutive days for subjects in either Cohort 2 or Cohort 3.
Subjects will participate only in Part 1 or in one of the 2 cohorts in Part 2.

The first part of the study will determine PK dose proportionality by using 3 single doses. The second part of the study will allow for determination of steady-state PK and accumulation ratio by once daily administration for 14 days.
Intervention code [1] 266654 0
Treatment: Drugs
Comparator / control treatment
Matching Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 266840 0
Part 1: To evaluate the safety and tolerability of rising single oral doses of SCH 900931 administered to healthy adult Japanese subjects. (Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)
Timepoint [1] 266840 0
Assessed throughout the study at each study visit up to Day 6 of period 3.
Primary outcome [2] 266878 0
Part 2: To evaluate the safety and tolerability of rising multiple oral doses of SCH 900931 administered to healthy adult Japanese subjects. (Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)
Timepoint [2] 266878 0
Assessed throughout the study at each study visit up to Day 21.
Secondary outcome [1] 276486 0
Part 1: To compare the single dose pharmacokinetic of SCH 900931 in healthy adult Japanese subjects to those obtained from healthy adult non-Japanese subjects (historical data from previous studies). (Assessed via pharmacokinetic blood sampling)
Timepoint [1] 276486 0
Assessed throughout the study at each study visit up to Day 6 of period 3 (part 1)
Secondary outcome [2] 276554 0
Part 2: To obtain preliminary plasma pharmacokinetic data of SCH 900931 following multiple oral dose administration in healthy adult Japanese subjects.

(Assessed via pharmacokinetic blood sampling)
Timepoint [2] 276554 0
Assessed throughout the study at each study visit up to or Day 21 (Part 2).

Eligibility
Key inclusion criteria
Healthy Japanese volunteers
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C

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
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267142 0
Commercial sector/Industry
Name [1] 267142 0
Schering-Plough Research Institute, a Division of Schering Corporation, a Subsidiary of Merck & Co., Inc
Country [1] 267142 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Schering-Plough Research Institute, a Division of Schering Corporation, a Subsidiary of Merck & Co., Inc
Address
2000 Galloping Hill Road
Kenilworth, New Jersey 07033
USA
Country
United States of America
Secondary sponsor category [1] 264215 0
None
Name [1] 264215 0
Address [1] 264215 0
Country [1] 264215 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269131 0
Ethics committee address [1] 269131 0
Ethics committee country [1] 269131 0
Date submitted for ethics approval [1] 269131 0
05/05/2011
Approval date [1] 269131 0
Ethics approval number [1] 269131 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32664 0
Address 32664 0
Country 32664 0
Phone 32664 0
Fax 32664 0
Email 32664 0
Contact person for public queries
Name 15911 0
Associate Professor Peter Hodsman
Address 15911 0
Level 5, Burnet Tower, AMREP Precinct, 89 Commercial Road, Melbourne Victoria 3004
Country 15911 0
Australia
Phone 15911 0
(61) 3 9076 8900
Fax 15911 0
Email 15911 0
[email protected]
Contact person for scientific queries
Name 6839 0
Associate Professor Peter Hodsman
Address 6839 0
Level 5, Burnet Tower, AMREP Precinct, 89 Commercial Road, Melbourne Victoria 3004
Country 6839 0
Australia
Phone 6839 0
(61) 3 9076 8900
Fax 6839 0
Email 6839 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.