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Trial record 1 of 1 for:    Lu AF82422
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Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03611569
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lu AF82422

Part A:

Cohorts A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4: 12 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects (aiming for an equal number of men and women)

Part B:

Cohort B1: 8 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:

Cohorts A1, A2, and A3: 24 healthy subjects, with 8 subjects per cohort (aiming for an equal number of men and women) Cohort A4: 12 healthy subjects, with 6 non-Japanese subjects and 6 Japanese subjects (aiming for an equal number of men and women)

Part B:

Cohort B1: 8 patients with Parkinson's disease

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




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



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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.


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


Contacts
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Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com

Locations
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United States, California
California Clinical Trials Medical Group (CCTMG) Recruiting
Glendale, California, United States, 91206
Contact: Email contact via H. Lundbeck A/S       LundbeckClinicalTrials@Lundbeck.com   
United States, Florida
Bioclinica Research Not yet recruiting
Orlando, Florida, United States, 32806
Contact: Email contact via H. Lundbeck A/S       LundbeckClinicalTrials@Lundbeck.com   
United States, Maryland
Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital Not yet recruiting
Baltimore, Maryland, United States, 21225
Contact: Email contact via H. Lundbeck A/S       LundbeckClinicalTrials@Lundbeck.com   
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03611569     History of Changes
Other Study ID Numbers: 17699A
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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