Comparison of ND0701 and Apomorphine PK in Healthy Subjects(QCL117759)
Research type
Research Study
Full title
A Phase I, Open-Label, Randomised, Single Centre, 3 Single Doses, 3-Way Cross Over Study to Compare the Pharmacokinetics of ND0701 with Apomorphine (Apo-Go®) in Healthy Subjects
IRAS ID
202166
Contact name
Liat Adar
Contact email
Sponsor organisation
NeuroDerm Ltd
Eudract number
2016-000534-21
Duration of Study in the UK
0 years, 1 months, 28 days
Research summary
The Sponsor is developing a new formulation of apomorphine, the study drug ND0701, for the potential treatment of Parkinson’s disease. \n\nThe study will try to identify how the body takes up the study drug when given as a subcutaneous infusion (injection just under the skin of the abdomen), over a 12 hour period. Two different concentrations of ND0701 will be studied, and compared to an existing apomorphine product, Apo-Go®, currently used to treat Parkinson’s disease. The safety and tolerability of each treatment will also be assessed.\n\nThe study will be a three-way crossover study involving up to 18 healthy male and female subjects. Subjects will be randomised into three groups, with each group receiving the three test products in a different order over three days, with a 12 hour gap between each product.
REC name
Wales REC 1
REC reference
16/WA/0092
Date of REC Opinion
3 May 2016
REC opinion
Further Information Favourable Opinion