Study to assess oral tolerability of Levodopa/Carbidopa (QCL117546)
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
172445
Contact name
Yael Cohen
Contact email
Sponsor organisation
NeuroDerm Ltd
Eudract number
2015-000278-36
Duration of Study in the UK
0 years, 0 months, 23 days
Research summary
The Sponsor is developing a new levodopa/carbidopa (LD/CD) solution with a new subcutaneous route of administration. As part of its clinical development plan, the sponsor intends to conduct trials to assess the bioequivalence of its new LD/CD solution to marketed LD/CD products in healthy volunteers. To facilitate the planning of these future studies, the sponsor first wants to assess the tolerability of a marketed LD/CD product (Sinemet®) administered as 16 consecutive doses to healthy subjects.
The study will consist of a single study period involving up to 6 healthy male and female subjects. Subjects will be pretreated on Day-1 with 3 doses of Sinemet® 100mg (2x50mg), given at 8 hour intervals. On Day 1, subjects will receive a dose of Sinemet® 50mg every hour for 16 doses. Subjects will be discharged on Day 2.
Subjects will also be given domperidone (Motilium®) prior to dosing with Sinemet® and then at regular intervals throughout the study to reduce the side effects of nausea and vomiting associated with combination levodopa/carbidopa.
REC name
Wales REC 2
REC reference
15/WA/0062
Date of REC Opinion
25 Feb 2015
REC opinion
Unfavourable Opinion