Multiple Dose Drug-Drug Interaction Study of AFQ056 & Sinemet

• Research type

  Research Study

• Full title

  An open-label, randomized, multiple dose, three-period, crossover study in healthy subjects to evaluate the pharmacokinetic interaction of AFQ056 and Sinemet® (levodopa and carbidopa).

• IRAS ID

  18134

• Sponsor organisation

  Novartis Healthcare Pvt. Ltd.

• Eudract number

  2009-009325-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  <table cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-right: 9pt; padding-left: 9pt; padding-bottom: 0cm; padding-top: 0cm"> For Parkinson's sufferers taking certain medications like Sinemet (levodopa & carbidopa) can mean that they can suffer a side effect called dyskinesia associated with Parkinson's Disease. Dyskinesia is where the body can go into spasms or tics. Once these drug-induced dyskinesias occur they will persist even after stopping Sinemet and can be triggered by other similar drugs. AFQ056 is a new drug in development aimed at reducing these drug-induced dyskinesias and it is intended that it will be taken together with Sinemet. The aim of this study is to find out if there is any interaction between AFQ056 & Sinemet. The study will be looking particularly at the amount of each drug that's absorbed into the blood stream and the length of time that it remains in the system when given alone and in combination with each other. The study will last for approx 76 days for each subject which includes 28 days screening period, 6 days in the unit for each treatment period and at least 10 days washout period. Twenty four healthy volunteers will be enrolled with the aim of 18 completing. </td> </tr> </tbody></table>

• REC name

  HSC REC B

• REC reference

  09/NIR03/29

• Date of REC Opinion

  23 Mar 2009

• REC opinion

  Further Information Favourable Opinion