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).
- 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.Neurological - Multiple sclerosis
- Registration Number
- ACTRN12613000545763
- Lead Sponsor
- ovartis Pharmaceuticals Australia Pty Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters from the plasma concentration-time data.<br>[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).]
- Secondary Outcome Measures
Name Time Method Safety and tolerability assessed through physical examinations, vital signs evaluations, hematology tests, cardiac safety monitoring and completion of a prospective suicidality assessment questionnaire.[From Day 1 to Day 42 for Part 1 and from Day 1 to Day 4 for Part 2 of the study.<br>]