Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in healthy young Japanese men in comparison with Caucasian men.

Detailed Description
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The study will be conducted in two parts. Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind, parallel-group, placebo-controlled, single- and multiple dose regimens investigating the safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men. Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over, single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in healthy young Japanese men.

Official Title
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Interventional, Randomised, Double-blind, Placebocontrolled, Single- and Multiple-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Cohort A1: Lu AE58054 or placebo
* Drug: Cohort A2: Lu AE58054 or placebo
* Drug: Cohort B1: Lu AE58054


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese (Japanese passport, four Japanese grandparents, and lives outside Japan for less than 5 years) or Caucasian men aged 20 to 45 years with a BMI between 18 and 25 kg/m2 (extremes included). Exclusion Criteria: The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A1: Lu AE58054 or placebo<br> | Drug: Cohort A1: Lu AE58054 or placebo<br>* One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.<br>|
| Experimental: Cohort A2: Lu AE58054 or placebo<br> | Drug: Cohort A2: Lu AE58054 or placebo<br>* One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.<br>|
| Experimental: Cohort B1: Lu AE58054<br> | Drug: Cohort B1: Lu AE58054<br>* Two single oral doses 60 mg with >=7 days washout.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and frequency of adverse events | Standard clinical safety assessments | Up to Day 13 | 
| Number of subjects with adverse events | Adverse event monitoring | Up to Day 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Lu AE58054 plasma concentration-time curve in a dosing interval (AUC0-tau) |  | Day 9 | 
| Area under the Lu AE58054 plasma concentration-time curve from zero to infinity (AUC0-inf) |  | Day 1 | 
| Maximum observed concentration (Cmax) and time of observation (tmax) |  | Day 1 and Day 9 | 
| Oral clearance (CL/F), apparent volume of distribution (Vz/F), and elimination halflife (t½) |  | Day 1 and Day 9 | 
| Accumulation index following multiple dosing of Lu AE58054 (AI) |  | Day 9 | 
| Risk of Suicidality | Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbian Classification Algorithm for Suicide Assessment (C-CASA) definitions for Part A | Up to Day 13 |