Investigation of Dose Titration effect of FTY720 in Healthy Volunteers

• Research type

  Research Study

• Full title

  A Double Blind, Placebo Controlled, Parallel Group Study to Investigate Two Different Dose-Titration Regimens of Fingolimod on the Negative Chronotropic Effect of Fingolimod in Healthy Subjects.

• IRAS ID

  87964

• Contact name

  Ronnie Beboso

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-002467-19

• Research summary

  This is single-centre, double-blind, placebo-controlled, dose titration, once daily, multiple oral dose study in healthy volunteers. 60 healthy volunteers will be enrolled. The study drug is approved in the US & other countries for the treatment of multiple sclerosis (MS). Initiation of the study drug at 0.5 mg daily dosing is associated with lowering of mean heart rate by approximately 10 beats/minute within hours of the first dose. Subsequently, current labelling requires patients to be observed in the clinic, at least six hours after administration of the first dose. This study is testing the effectiveness of two different one month titration regimens in reducing the heart rate lowering drug effect . Both titration regimens use a stepped approach in which a dose lower than the clinical dose is used for treatment initiation. This dose is then escalated to the clinical dose over a one month period.Based on the results of this study, one of these regimens will be used in a pivotal study of treatment initiation in MS patients. The aim is for patients to use the treatment at home, not requiring clinical observation.To track medication adherence and monitor heart rate, a Proteus Personal Monitor (PPM) system will be used. An Ingestible Event Marker (IEM) will be swallowed by the volunteer along with the study medication. The IEM transmits information to a device; Proteus Personal Monitor placed on the chest. This in turn sends information to a mobile phone device which transmits the information to a central data storage base. This allows close monitoring of the study drug (clinic and home settings) & heart rate each day of the study.Day -7 will commence PPM training, volunteers will use the system at home for 5 days to determine adherence and eligibility for study participation.Study duration - approximately 33 days (excl 21 day screening period).

• REC name

  HSC REC B

• REC reference

  11/NI/0144

• Date of REC Opinion

  6 Oct 2011

• REC opinion

  Further Information Favourable Opinion