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

Phase 1

Completed

• Conditions: Healthy; Parkinson Disease
• Interventions: Drug: Placebo; Drug: Lu AF82422

• Registration Number: NCT03611569
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-25
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	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
Lu AF82422	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

Primary Outcome Measures

Name	Time	Method
Number of patients with Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	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

Name	Time	Method
AUC 0-t	From dosing to Day 84	Area under the Lu AF82422 plasma concentration curve from zero to time t
Cmax	From dosing to Day 84	Maximum observed plasma concentration of Lu AF82422
CL	From dosing to Day 84	Clearance of Lu AF82422

Trial Locations

Locations (4)

California Clinical Trials Medical Group (CCTMG); 🇺🇸 Glendale, California, United States

Reserach Center of America; 🇺🇸 Hollywood, Florida, United States

PPD; 🇺🇸 Orlando, Florida, United States

Parexel, Early Phase Clinical Unit (EPCU), Harbor Hospital; 🇺🇸 Baltimore, Maryland, United States