Back to resultsA Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Levodopa-Carbidopa
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring Parkinson's Disease, levodopa, carbidopa, Duodopa, intestinal gel
Eligibility Criteria
Inclusion Criteria
- Male or female subjects at least 30 years old;
- Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
- Body mass index range from 18.0 to 30.0 kg/m2
Exclusion Criteria
- Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
- Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Profile of Pharmacokinetics
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01484990
First Posted
July 28, 2011
Last Updated
November 17, 2017
Sponsor
AbbVie
Collaborators
Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01484990
Brief Title
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Official Title
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Quintiles, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, levodopa, carbidopa, Duodopa, intestinal gel
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levodopa-Carbidopa
Intervention Description
Intestinal Gel
Primary Outcome Measure Information:
Title
Profile of Pharmacokinetics
Description
Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.
Time Frame
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.
Title
Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam)
Description
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)
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Male or female subjects at least 30 years old;
Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
Body mass index range from 18.0 to 30.0 kg/m2
Exclusion Criteria
Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Benesh
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
23229334
Citation
Nyholm D, Odin P, Johansson A, Chatamra K, Locke C, Dutta S, Othman AA. Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients. AAPS J. 2013 Apr;15(2):316-23. doi: 10.1208/s12248-012-9439-1. Epub 2012 Dec 11.
Results Reference
result
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A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
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