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).
Criteria:- Male and female subjects, ages 45 to 75 years, inclusive, at the time of signing the informed consent form (ICF).
- Body mass index (BMI) of 17.5 to 38.0 kg/m2 and a total body weight >50 kg (110 lbs).
- Subjects with a diagnosis of that is consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria, with bradykinesia and motor asymmetry.
- Must be modified Hoehn & Yahr (HY) Stage I - III inclusive.
- 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. Must be willing and able to refrain from L-Dopa treatment (in Part 1 and Part 2B) as outlined in the schedule of assessments.
- A female subject of childbearing potential (see Section 10.4, Appendix 4) who is sexually active with a nonsterilized male partner or male subject with a pregnant or a nonpregnant partner of childbearing potential must agree to use an acceptable or a highly effective method of contraception (see Section 10.4, Appendix 4) from signing of informed consent throughout the duration of the trial and for 7 days post last dose.
- Capable of giving signed informed consent as described in Section 10.1.3 (Appendix 1), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
- Capable of consuming the standard high-fat meal.
Qualified Participants May Receive:
Compensation for participating up to $900.00 over the study length (217 days).