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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Levodopa-Carbidopa

• Registration Number: NCT01484990
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-07-28
• Status Verified: 2011-11
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Levodopa-Carbidopa	-

Primary Outcome Measures

Name	Time	Method
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)
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.