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

November 17, 2017 updated by: AbbVie
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: Levodopa-Carbidopa
Intestinal Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Pharmacokinetics
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.
Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.
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.
Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam)
Time Frame: 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)
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

Quintiles, Inc.

Investigators

  • Study Director: Janet Benesh, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (ESTIMATE)

December 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S187.1.002
  • 2009-016837-84 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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