Clinical trial NCT03611569: Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Parkinson Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cohort
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: From dosing to Day 84
Secondary outcomes:
measure: AUC 0-t
timeFrame: From dosing to Day 84
measure: Cmax
timeFrame: From dosing to Day 84
measure: CL
timeFrame: From dosing to Day 84
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials Medical Group (CCTMG)
state: California
city: Hollywood
country: United States
facility: Reserach Center of America
state: Florida
city: Orlando
country: United States
facility: PPD
state: Florida
city: Baltimore
country: United States
facility: Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital
state: Maryland
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: