Safety and Tolerability of Lu AF95245 in Healthy Young Men

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug

Detailed Description
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The study is divided in two parts, Part A and Part B: Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men. Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3) Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.

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 AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF95245
* Drug: Lu AF95245 14C radiolabelled spiked dosage
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, young, non-smoking men with a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit. Exclusion Criteria: The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP. Other in- 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: Cohort A: sequential, cohort B parallel
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A: single-ascending oral dose<br>Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential | Drug: Lu AF95245<br>* solution, single dose, orally<br>Drug: Placebo<br>* solution, single dose, orally<br>|
| Experimental: Cohort B: (fasting/fed conditions)<br>Groups B1, B2, and B3, with 4 subjects in each group and the groups will be running in parallel. B1: fed-fasting-fasting condition (spiked dosage) B2: fasting-fed-fasting condition (spiked dosage) B3: fasting-fasting-fed condition | Drug: Lu AF95245<br>* solution, single dose, orally<br>Drug: Lu AF95245 14C radiolabelled spiked dosage<br>* solution, single dose, orally<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 baseline to Day 14 | 
| AUC(0-inf) Lu AF95245 | Area under the plasma concentration time curve from zero to infinity | From 0 to 96 hours | 
| Cmax Lu AF95245 | Maximum observed plasma concentration | From 0 to 96 hours | 
| CL/F Lu AF95245 | Oral clearance for Lu AF95245 in plasma | From 0 to 96 hours | 
| Total recovery of the administered dose (% of dose in urine and faeces) | Excretion of labelled Lu AF95245 in urine and faeces | From 0 to Day 14 |