Pharmacokinetics of Levodopa/Carbidopa and Duodopa (QCL117480)
Research type
Research Study
Full title
A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects: Part 1 (ND0612-005a) to Identify the Concentration of Carbidopa that Provides Optimal Bioavailability of a Concomitant Fixed Concentration of Levodopa Infused Subcutaneously via a Pump System; Part 2 (ND0612-005b) to Compare the Bioavailability of the Optimal Levodopa/Carbidopa Solution to that of Duodopa®, a Levodopa/Carbidopa Intestinal Gel Infused via a Naso-Jejunal Tube
IRAS ID
174982
Contact name
Yael Cohen
Contact email
Sponsor organisation
NeuroDerm Ltd
Eudract number
2014-005483-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 23 days
Research summary
The Sponsor is developing a levodopa (LD)/carbidopa (CD) combination therapy via a new route of delivery (subcutaneous) for use in the treatment of the neurological disorder Parkinson's disease. The existing approved LD and CD combination products are administered orally or as an intestinal gel administered by a portable pump via a tube which has been surgically fitted through the stomach into the intestine. A continuous dose can prevent and reduce motor function complications associated with the disease such as tremor, muscle stiffness and slowness of movement, which can be seen when dosing orally due to the peaks and troughs of drug in the body. A subcutaneous infusion would provide patients with a continuous dose of study drug, which would have only previously been available with surgery.
As part of the clinical development plan, the Sponsor intends to assess the bioequivalence of the subcutaneous investigational medical product compared to a marketed LD/CD intestinal gel product (Duodopa®). The study will consist of two parts. In Part 1 a fixed dose of LD will be combined with varying doses of CD and given subcutaneously to see how different CD doses affect the amount of LD that is taken up by the body. This is not only to identify the most effective LD/CD dose combination for use in Part 2, but will allow assessment of bioequivalence compared to marketed oral products which are currently available.
Part 2 will look at the amount of LD taken up by the body following naso-jejunal administration of Duodopa® (LD/CD intestinal gel) and will allow comparison of the bioavailability of the most effective LD/CD solution from Part 1 with that of Duodopa®.
The safety and tolerability of the study treatments will be assessed in both parts of the study.
REC name
Wales REC 1
REC reference
15/WA/0078
Date of REC Opinion
7 May 2015
REC opinion
Further Information Favourable Opinion