Assessment of tolerability of Levodopa/Carbidopa (117546) Resubmission

• Research type

  Research Study

• Full title

  A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach

• IRAS ID

  177888

• Contact name

  Yael Cohen

• Contact email

  yael@neuroderm.com

• Sponsor organisation

  NeuroDerm Ltd

• Eudract number

  2015-000278-36

• Duration of Study in the UK

  0 years, 0 months, 18 days

• Research summary

  The purpose of this proposed study is to assess gastrointestinal (GI) tolerance to 16 consecutive doses of levodopa/carbidopa (LD/CD) administered orally every hour. The study is designed as a prelude to a follow-on study due to be conducted by the sponsor using LD/CD administered continuously over 16 hours via a naso-jejunal tube in healthy subjects.
  In this proposed clinical study, subjects will receive a 50 mg dose of Sinemet® (a licenced oral tablet of LD/CD) administered each hour for 16 consecutive doses on Day 1 in order to mimic a continuous administration of approximately the same dose of LD/CD via a naso-jejunal tube over 16 hours. Subjects will receive a prophylactic anti-emetic treatment with domperidone 10-20mg every 8 hours for 24 h before and during any LD/CD doses to minimise the GI side effects. They will also receive a low total dose of 100mg Sinemet every 8 hours within the day prior (Day-1) to the study day. The purpose of this Day-1 Sinemet dosing is to promote an initial tolerance to the LD/CD combination.

• REC name

  Wales REC 2

• REC reference

  15/WA/0069

• Date of REC Opinion

  19 Mar 2015

• REC opinion

  Favourable Opinion