Clinical Trial 44345

Long Beach, CA 90806


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).



Inclusion Criteria:

  1. Male and female subjects, ages 45 to 75 years, inclusive, at the time of signing the informed consent form (ICF).
  2. Body mass index (BMI) of 17.5 to 38.0 kg/m2 and a total body weight >50 kg (110 lbs).
  3. Diagnosed with Parkinson's  Disease
  4. Must be on a stable dose of L-Dopa of at least 300 mg daily in conjunction with a dopa-decarboxylase inhibitor (eg, L-Dopa/carbidopa or L-Dopa/benserazide) administered at least 3 times per day but no more than 6 times per day for at least 2 weeks prior to the Day 1 Visit. 


Qualified Participants May Receive:

Compensation up to $3,015, complimentary meals and transportation, no cost investigational treatment or placebo, and study-related procedures.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.