A 2-Part Trial of CVL-751 in Subjects With Parkinson's Disease
Status:
Completed
Trial end date:
2021-07-23
Target enrollment:
Participant gender:
Summary
This trial will be a 2-part, adaptive, open label, single and/or multiple oral dose, safety,
tolerability, food effect trial of CVL-751 in subjects with Parkinson's disease. Part 1 is a
placebo-controlled, single dose cohort intended for assessment of safety and tolerability. In
case of intolerable AEs, Part 2 would proceed as a multiple dose titration trial to achieve a
15 mg once daily dose while maintaining L-Dopa treatment (Part 2A). In case of a favorable
tolerability profile in Part 1, Part 2B would proceed as a single dose trial (similar to Part
1), with discontinuation of L-Dopa for 24 hours (12 hours pre-Day 1 dose and 12 hours
post-Day 1 dose).