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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01652313
Collaborator
(none)
12
Enrollment
1
Location
1
Arm

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2012
Actual Primary Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rasagiline

Drug: Rasagiline
1 mg/day, tablets for 7 days, orally
Other Names:
  • Lu 00-773; Azilect®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI) [7 days]

    2. PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI) [7 days]

    Secondary Outcome Measures

    1. Number of patients with adverse events as a measure of safety and tolerability [7 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CN001 Beijing China

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

    • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@lundbeck.com

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT01652313
    Other Study ID Numbers:
    • 13496A
    First Posted:
    Jul 30, 2012
    Last Update Posted:
    Jul 30, 2012
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Parkinson Disease
    Rasagiline

    Study Results

    No Results Posted as of Jul 30, 2012