Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611569
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease

Condition or disease Intervention/treatment Phase
Healthy Parkinson Disease Drug: Lu AF82422 Drug: Placebo Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Cohort
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
Actual Study Start Date : July 25, 2018
Actual Primary Completion Date : July 26, 2021
Actual Study Completion Date : July 26, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Lu AF82422

Part A:

Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)

Part B:

Cohort B1, B2, B3: 24 patients with Parkinson's disease

 Drug: Lu AF82422
Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
Placebo Comparator: Placebo

Part A:

Cohort A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4,A5,A6: 36 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects per cohort (aiming for an equal number of men and women)

Part B:

Cohort B1, B2, B3: 24 patients with Parkinson's disease

 Drug: Placebo
placebo - concentrate for solution for infusion, single dose


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: From dosing to Day 84 ]
    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)


Secondary Outcome Measures :
  1. AUC 0-t [ Time Frame: From dosing to Day 84 ]
    Area under the Lu AF82422 plasma concentration curve from zero to time t

  2. Cmax [ Time Frame: From dosing to Day 84 ]
    Maximum observed plasma concentration of Lu AF82422

  3. CL [ Time Frame: From dosing to Day 84 ]
    Clearance of Lu AF82422


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy subjects:

- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)

Patients with Parkinson's disease:

  • Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H&Y, stage 1-3)
  • For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI
  • If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI
  • ≥40 and ≤80 years of age
  • BMI ≥18 and ≤35 kg/m2

Exclusion criteria:

  • Atypical Parkinsonism
  • Clinically relevant structural brain abnormality, as assessed using MRI
  • Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =<21
  • Any past or current treatment with an active vaccine targeting alpha-synuclein
  • Any past or current treatment with a monoclonal antibody within the last 12 months

Other in- and exclusion criteria may apply.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611569


Locations
Layout table for location information
United States, California
California Clinical Trials Medical Group (CCTMG)
Glendale, California, United States, 91206
United States, Florida
Reserach Center of America
Hollywood, Florida, United States, 33024
PPD
Orlando, Florida, United States, 32806
United States, Maryland
Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Layout table for investigator information
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03611569    
Other Study ID Numbers: 17699A
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases