NCT01652313

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

July 23, 2012

Last Update Submit

July 25, 2012

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI)

    7 days

  • PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI)

    7 days

Secondary Outcomes (1)

  • Number of patients with adverse events as a measure of safety and tolerability

    7 days

Study Arms (1)

Rasagiline

EXPERIMENTAL
Drug: Rasagiline

Interventions

RasagilineDRUG

1 mg/day, tablets for 7 days, orally

Also known as: Lu 00-773; Azilect®
Rasagiline

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CN001

Beijing, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 30, 2012

Study Start

May 1, 2012

Primary Completion

June 1, 2012

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

CN(1)