Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and Women

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652313
• Other study ID #: 13496A
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2012
• Last updated: July 25, 2012
• Start date: May 2012

Study information

• Verified date: July 2012
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rasagiline
1 mg/day, tablets for 7 days, orally

Locations

Country	Name	City	State
China	CN001	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)		7 days	No
Primary	PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)		7 days	No
Secondary	Number of patients with adverse events as a measure of safety and tolerability		7 days	Yes