A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT01484990

Collaborator

Quintiles, Inc. (Industry)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Levodopa-Carbidopa	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Levodopa-Carbidopa Intestinal Gel

Arm

Intervention/Treatment

Experimental: 1

Drug: Levodopa-Carbidopa

Intestinal Gel

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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