Open-label study to assess the pharmacokinetics, safety and tolerability of siponimod in healthy subjects with CYP2C9 extensive (EM) and poor metabolizer (PM) phenotype.

ovartis Pharmaceuticals Australia Pty Limited0 sites24 target enrollmentMay 15, 2013

ConditionsThe 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.Neurological - Multiple sclerosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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.
Sponsor: ovartis Pharmaceuticals Australia Pty Limited
Enrollment: 24
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 15, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

ovartis Pharmaceuticals Australia Pty Limited

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Not specified

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