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Trial registered on ANZCTR
Registration number
ACTRN12613000545763
Ethics application status
Approved
Date submitted
4/05/2013
Date registered
15/05/2013
Date last updated
17/12/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Open-label study to assess how the pharmacokinetics (i.e. the way the body absorbs, distributes and gets rid of a drug), safety, and tolerability of the drug siponimod are influenced by the presence of specific genetic characteristics (namely CYP2C9 genotypes).
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Scientific title
Open-label study to assess the pharmacokinetics, safety and tolerability of siponimod in healthy subjects with CYP2C9 extensive (EM) and poor metabolizer (PM) phenotype.
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
CBAF312A2128
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The medical condition pursued for siponimod is Secondary Progressive Multiple Sclerosis (SPMS). This study aims to characterize the PK profile of siponimod in healthy subjects with the CYP2C9 extensive and poor metabolizer phenotype.
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Condition category
Condition code
Neurological
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0
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Multiple sclerosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study is divided in two parts: Part 1 and Part 2. All subjects will complete Part 1 and will be single dosed with Siponimod (BAF312) administered as a 0.25mg oral tablet. After a wash-out period of approximately 6 weeks, only subjects belonging to the poor metabolizer phenotype will roll over to Part 2 when subjects will be dosed in 3 separate consecutive days with Siponimod (BAF312) administered as an oral tablet (Day 1: 0.25 mg; Day 2: 0.25 mg; Day 3: 0.5 mg). Subjects presenting the CYP2C9 *1/*1 genotype are not eligible for Part 2. The genotype group is assessed through a CLIA-validated blood assay in Part 1 of the study, or Part 2 for replacement subjects. To monitor adherence, subjects will be confined to the study site for 3 days during Part 1, and for 5 days during Part 2.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Early detection / Screening
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Comparator / control treatment
No comparator
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Pharmacokinetic parameters from the plasma concentration-time data.
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Assessment method [1]
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Timepoint [1]
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From Day 1 to Day 42 for Part 1 (17 samples following pre-specified hourly intervals from Day 1 to Day 3, and 11 samplings, at pre-specified daily intervals from Day 4 to Day 42), and from Day 1 to Day 4 for Part 2 of the study (16 samples in total, of which 13 on Day 3).
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Secondary outcome [1]
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Safety and tolerability assessed through physical examinations, vital signs evaluations, hematology tests, cardiac safety monitoring and completion of a prospective suicidality assessment questionnaire.
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Assessment method [1]
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Timepoint [1]
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From Day 1 to Day 42 for Part 1 and from Day 1 to Day 4 for Part 2 of the study.
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Eligibility
Key inclusion criteria
1) Healthy male and female subjects aged 18 to 70 years, inclusive.
2) Female subjects must be of non-child bearing potential.
3) Body weight: greater than or equal to 50.0 kg; BMI: 18.0-30.0 kg/m2, inclusive.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1) Subjects with CYP2C9 *1/*2, *2/*2, and *1/*3 genotypes according to screening results.
2) Clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases which has not resolved within two weeks prior to initial dosing.
3) History or presence (=screening or first baseline) of any clinically significant ECG abnormalities.
4) Any clinically significant laboratory abnormalities at screening that may jeopardize the subjects' safety throughout the study (as judged by the investigator).
5) Smokers as defined by reported tobacco use or urine cotinine concentrations greater than or equal to 500 ng/mL at screening or baseline visit.
6) Use of any prescription drug, herbal drug or over-the-counter medication from four weeks prior to initial dosing.
7) Pregnant or nursing (lactating) females.
8) Any surgical or medical condition which, as judged by the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
The study is divided in two parts (Part 1 and Part 2). All subjects will complete Part 1 and will be single dosed with Siponimod (BAF312). Only specific genotypes will roll over to Part 2 where subjects will be dosed in 3 separate days with Siponimod (BAF312).
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Phase
Phase 1
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Type of endpoint/s
Pharmacokinetics
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Statistical methods / analysis
Log-transformed PK parameters for siponimod, will be analyzed by a fixed effects model. The sample size per genotype group is considered to yield satisfactory precision in the estimation of the effect of phenotype, as measured by the ratio of the PK parameter.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/05/2013
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Actual
23/05/2013
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Date of last participant enrolment
Anticipated
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Actual
14/01/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
24
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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France
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State/province [1]
5061
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Country [2]
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Jordan
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State/province [2]
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Country [3]
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United States of America
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State/province [3]
5063
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Novartis Pharma AG
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Address [1]
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Novartis Pharma AG
Postfach
CH-4002 Basel
Switzerland
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Country [1]
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Switzerland
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Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals Australia Pty Limited
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Address
54 Waterloo Rd
North Ryde, NSW 2113
Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Alfred Ethics Committee
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Ethics committee address [1]
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Ground Floor, Linay Pavilion, The Alfred hospital
55 Commercial Road
Melbourne 3004
Victoria
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/03/2013
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Approval date [1]
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09/04/2013
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Ethics approval number [1]
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96/13
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Summary
Brief summary
Clinical study aiming to assess how the pharmacokinetics (i.e. the way the body absorbs, distributes and gets rid of a drug), safety, and tolerability of the drug siponimod are influenced by the presence of specific genetic characteristics (namely CYP2C9 genotypes).
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Trial website
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Trial related presentations / publications
To date (December 15, 2015) no publications have been generated based on this clinical trial
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Public notes
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Contacts
Principal investigator
Name
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Dr Jason Lickliter
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Address
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Nucleus Network Ltd
Level 5, Burnet Building,
89 Commercial Rd, Melbourne 3004 VIC
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Country
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Australia
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Phone
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+613 9076 8906
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jason Lickliter
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Address
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Nucleus Network Ltd
Level 5, Burnet Building,
89 Commercial Rd, Melbourne 3004 VIC
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Country
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Australia
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Phone
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+613 9076 8906
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Mike Ufer
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Address
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Novartis Campus
CH-4056 Basel
Switzerland
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Country
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Switzerland
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Phone
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+41 79 7235979
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Fax
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Email
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[email protected]
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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.
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