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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

Tracking Information
First Submitted Date  ICMJE July 26, 2018
First Posted Date  ICMJE August 2, 2018
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE July 25, 2018
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03611569 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • AUC 0-t [ Time Frame: From dosing to Day 84 ]
    Area under the Lu AF82422 plasma concentration curve from zero to time t
  • Cmax [ Time Frame: From dosing to Day 84 ]
    Maximum observed plasma concentration of Lu AF82422
  • CL [ Time Frame: From dosing to Day 84 ]
    Clearance of Lu AF82422
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Cohort
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Parkinson Disease
Intervention  ICMJE
  • Drug: Lu AF82422
    Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
  • Drug: Placebo
    placebo - concentrate for solution for infusion, single dose
Study Arms  ICMJE
  • 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

    Intervention: Drug: Lu AF82422
  • 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

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Email contact via H. Lundbeck A/S +45 36301311 LundbeckClinicalTrials@Lundbeck.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03611569
Other Study ID Numbers  ICMJE 17699A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP