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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01652313
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: Rasagiline
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Pharmacokinetic (PK) AUC determination of rasagiline and its metabolite 1-aminoindan (1-AI) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • PK Cmax determination of rasagiline and its metabolite 1-aminoindan (1-AI) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rasagiline Drug: Rasagiline
1 mg/day, tablets for 7 days, orally
Other Name: Lu 00-773; Azilect®

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652313

Locations
China
CN001
Beijing, China
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01652313     History of Changes
Other Study ID Numbers: 13496A
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014