Back to resultsPharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Rasagiline
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- The subject is a Chinese man or woman
- The subject is, in the opinion of the investigator, generally healthy
- If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit
Exclusion Criteria:
- The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Other inclusion and exclusion criteria may apply.
Sites / Locations
- CN001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rasagiline
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)
PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)
Secondary Outcome Measures
Number of patients with adverse events as a measure of safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01652313
Brief Title
Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
Official Title
A Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to fulfil regulatory requirements for registration of a new chemical entity in China. Rasagiline is approved for the treatment of Parkinson's Disease (PD) in Europe and the US. Rasagiline is safe and well tolerated in healthy subjects, and the efficacy and safety has been demonstrated in placebo- and active comparator-controlled phase III studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rasagiline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rasagiline
Other Intervention Name(s)
Lu 00-773; Azilect®
Intervention Description
1 mg/day, tablets for 7 days, orally
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)
Time Frame
7 days
Title
PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of patients with adverse events as a measure of safety and tolerability
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The subject is a Chinese man or woman
The subject is, in the opinion of the investigator, generally healthy
If female, the subject must have a negative pregnancy test at screening and baseline, and agree not to try to become pregnant from Screening until after the Follow-up Visit
Exclusion Criteria:
The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
CN001
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women
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