Phase 1b study in early stage Huntington's Disease patients SEN0014196

• Research type

  Research Study

• Full title

  An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients to Assess Pharmacokinetics, Candidate Pharmacodynamic Measures of Target Engagement and Disease Modulation as well as Acute Phenotypical Effects Following Multiple Oral Doses of SEN0014196

• IRAS ID

  66188

• Contact name

  Sarah Tabrizi

• Sponsor organisation

  Siena Biotech SpA

• Eudract number

  2010-021563-32

• ISRCTN Number

  Not known

• Research summary

  The study is an exploratory, multi-centre, randomised and double-blind placebo-controlled, parallel group design at two dose levels with once daily administration over two weeks in clinical stages I-II of Huntington's disease (HD) patients SEN0014196 is an investigational drug previously tested on healthy volunteers and will be tested for the first time on patients with HD. Previous studies in healthy volunteers have shown the drug to be safe and well tolerated. This study is expected to provide further information on how the compound works in humans and help further clinical development of SEN0014196. The study will be conducted at two different dose levels (10mg or 100mg of SEN0014196 given orally once daily), there will also be a placebo arm. The study will assess what the drug does to the body (Pharmacodynamic effect) and what the body does to the drug (Pharmacokinetics). To do this repeated blood samples will be taken for the duration of the study. Safety assessments will also be conducted including ECGs, Blood Pressure, Pulse, Body Temperature, Laboratory Safety tests and a Physical Exam. The total duration of the study is 28 days (14 days on treatment plus a 14 day Follow-up Period), excluding the Screening period. 60 patients(males & females aged 18 to 70) with early stage HD will be involved in this study which will be conducted across 6 sites in the EU.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/169

• Date of REC Opinion

  7 Feb 2011

• REC opinion

  Further Information Favourable Opinion