Primary Objective: To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD). Secondary Objectives: To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD. To compare the efficacy of IPX203 with IR CD-LD following multiple doses. To evaluate the safety of IPX203.
IPX203 is an investigational product containing CD-LD. IPX203-B16-01 Study Design: A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study. Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized. The study duration will be approximately 8 weeks, including the screening period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
Investigator 110
Little Rock, Arkansas, United States
Site 114
Little Rock, Arkansas, United States
Investigator 106
Boca Raton, Florida, United States
Levodopa Cmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Levodopa Tmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Levodopa t1/2 Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Levodopa AUCt Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Levodopa AUCinf Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Carbidopa Cmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Carbidopa Tmax Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigator 112
Naples, Florida, United States
Investigator 113
Port Charlotte, Florida, United States
Site 108
Tampa, Florida, United States
Investigator 101
Farmington Hills, Michigan, United States
Site 103
Durham, North Carolina, United States
Investigator 109
Cleveland, Ohio, United States
Site 115
Kirkland, Washington, United States
...and 1 more locations
Time frame: Day 1
Carbidopa t1/2 Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Carbidopa AUCt Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Carbidopa AUCinf Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose
Time frame: Day 1
Levodopa Cmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Time frame: Day 15
Levodopa Tmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Time frame: Day 15
Levodopa AUCtau Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Time frame: Day 15
Carbidopa Cmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Time frame: Day 15
Carbidopa Tmax Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Time frame: Day 15
Carbidopa AUCtau Following First Dose on Day 15
Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose.
Time frame: Day 15