Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

Study Overview
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Brief Summary
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The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men

Official Title
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Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF76432 in Healthy Young Men

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo
* Drug: Lu AF76432


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit. Exclusion Criteria: The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP Other inclusion and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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: Sequential Assignment
Interventional Model Description: 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo to Lu AF76432 | Drug: Placebo<br>* Placebo to Lu AF76432 oral solution<br>|
| Experimental: Lu AF76432<br>Lu AF76432 | Drug: Lu AF76432<br>* Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Treatment-Emergent Adverse Events | Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination) | From dosing to 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-t | Area under the plasma concentration-time curve from zero to time t | From dosing to 72 hours post dose | 
| Cmax | Maximum observed concentration | From dosing to 72 hours post dose | 
| AUC0-inf | Area under the plasma concentration-time curve from zero to infinity | From dosing to 72 hours post dose | 
| CL/F | Oral clearance | From dosing to 72 hours post dose |