A study of the safety and drug levels of CVT-301

• Research type

  Research Study

• Full title

  A phase 1 study of the safety and pharmacokinetics of single ascending doses of CVT-301 (levodopa inhalation powder) in healthy, adult subjects.

• IRAS ID

  92779

• Contact name

  Pui Man Leung

• Sponsor organisation

  Civitas Therapeutics, Inc.

• Eudract number

  2011-003945-17

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to assess a new drug which is being developed for the treatment of Parkinson's disease. One treatment currently available, levodopa, has been used effectively for over 40 years to treat Parkinson's disease. Levodopa is currently administered to patients as a pill. The drug being tested in this study is called CVT-301. It is an inhaled drug containing levodopa which has been shown in animal studies to work more quickly after it is taken (compared to levodopa given as a pill), and so could greatly benefit patients in controlling their symptoms. It is intended that CVT-301 will be used alongside the patient??s usual treatment. This will be a two-part study in healthy adult subjects as follows: ?½Part A: Dose Escalation Segment in 18 subjects ?½Part B: CVT-301 ñ Carbidopa* Segment in 8 subjects * This drug is currently taken along with levodopa treatment to enhance its effects This is the first time this medicine has been tested in humans through the inhaled route. This study will investigate the safety and tolerability of CVT-301 and also look into how CVT-301 is handled by the body (i.e. how fast the drug gets into the blood after it has been taken and how quickly the body removes it again).

• REC name

  Wales REC 1

• REC reference

  11/WA/0329

• Date of REC Opinion

  4 Nov 2011

• REC opinion

  Further Information Favourable Opinion