Parkinson Disease
Conditions
Keywords
Parkinson's Disease, levodopa, carbidopa, Duodopa, intestinal gel
Brief summary
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.
Interventions
Intestinal Gel
Sponsors
Quintiles, Inc.
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects at least 30 years old; 2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days; 3. Body mass index range from 18.0 to 30.0 kg/m2
Exclusion criteria
1. Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator; 2. Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments; 3. Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Pharmacokinetics | 5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours. | Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation. |
| Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam) | 2 days | Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2) |
Outcome results
None listed