Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: The objective of this study was to characterize pharmacokinetic profile of levodopa prodrug ONO-2160 in animal and human.
Background: Motor complications of Parkinson’s disease (PD) are a consequence of pulsatile dopaminergic stimulation from standard levodopa therapy. ONO-2160 is a prodrug of levodopa that was designed to be absorbed by passive diffusion throughout the GI tract to achieve steady levodopa plasma levels.
Methods: The nonclinical pharmacokinetic study of ONO-2160/CD and levodopa /carbidopa (LD/CD) suspension has been assessed in rat and dog. Phase 1 clinical study has been conducted in healthy volunteers and PD patients using ONO-2160/CD suspension. The single-dose pharmacokinetics of ONO-2160/CD (300/25 mg) versus immediate-release tablet (IR) LD/CD (100/10 mg) was evaluated in nine healthy subjects and eight PD patients. The multiple-dose pharmacokinetics of ONO-2160/CD (300/10 mg) was also evaluated in eight healthy subjects.
Results: The pharmacokinetic parameter of Cmax/C8hr of levodopa plasma concentration following a single dose of ONO-2160/CD in rat and dog were 29.9 and 6.1 fold lower than those from LD/CD, respectively. The relative bioavailability of ONO-2160/CD to LD/CD in rat and dog were 101% and 74%, respectively. Following single dose of ONO-2160/CD in healthy subjects and PD patients, the pharmacokinetic parameter of Cmax/C8h of ONO-2160/CD were 7.6 and 13.8 fold lower than those from LD/CD and relative bioavailabilities of those were 67% and 89%, respectively. Stable plasma profile of levodopa was observed in three times a day dosage of ONO-2160/CD in healthy subjects and the pharmacokinetic parameter of Cmax/Cmin of that was 2.2. ONO-2160/CD showed stable plasma concentration profile of levodopa and high relative bioavailabilities to IR LD/CD in animal and human.
Conclusions: These data suggest that ONO-2160/CD provides relatively stable LD levels compared with IR LD/CD in PD patients. Stable efficacy from ONO-2160/CD is promising.
To cite this abstract in AMA style:
M. Nomoto, M. Nagai, N. Nishikawa, K. Yano, Y. Kagamiishi, M. Akisada, S. Saito, M. Yuba, T. Koyanagi, A. Takeda. Pharmacokinetic profile of ONO-2160/CD (levodopa prodrug/carbidopa) in animal and human [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/pharmacokinetic-profile-of-ono-2160cd-levodopa-prodrugcarbidopa-in-animal-and-human/. Accessed June 14, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/pharmacokinetic-profile-of-ono-2160cd-levodopa-prodrugcarbidopa-in-animal-and-human/