A study to compare  pharmacokinetics and pharmacodynamics of an investigational drug to standard carbidopa-levodopa

Researchers want to find out if an investigational drug can help people with Parkinson’s disease.

Subjects who agree to participate will be given the investigational drug to compare the pharmacokinetics (PK, a measure of how the body absorbs and breaks down a drug) and pharmacodynamics (PD, how a drug works in the body) of the investigational drug with the PK and PD of carbidopa-levodopa after an initial dose.
Carbidopa-levodopa is already approved by the FDA to treat Parkinson’s disease. Another purpose of the study is to look at the PK effects of the investigational drug after more than one dose.

The study will recruit approximately 24 people with Parkinson’s disease who are at least 30 years old. Up to six may be enrolled at Rush University Medical Center. Each subject will get the investigational drug and CD-LD at different times during this study.

You may be eligible to participate in this study if you:

• Have been diagnosed with idiopathic Parkison's disease
• Are at least 30 years old at the time of diagnosis
• Had a Mini Mental State Examination (MMSE) ≥ 26 at screening
• Are a responder to levodopa and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD-LD for at least one month

You will be excluded from this study if you:

• Are pregnant or breastfeeding
• Have been diagnosed with atypical parkinsonism
• Have a history, physical findings or laboratory results suggesting a diagnosis other than Parkinson's disease
• Were allergic or nonresponsive to previous CD-LD therapy

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.