Single Dose of Lu AF28996 to Healthy Young Men

Study Overview
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Brief Summary
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This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.

Detailed Description
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Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between. Part B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences

Official Title
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Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF28996 solution
* Drug: Lu AF28996 capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criterium: Healthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF28996<br>Lu AF28996 solution, cohort depending dose Part A: Cohort 1: single oral dose of Lu AF28996 Cohorts 2-6: two single ascending oral doses of Lu AF28996 with a washout in between Possibility of 4 additional cohorts (Cohorts 7 to 10), allowing for the investigation of a potential 13 additional subjects Part B: 8 subjects (randomised to one of four treatment sequences) | Drug: Lu AF28996 solution<br>* Oral solution (0.1-0.2 mg/mL) Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses<br>Drug: Lu AF28996 capsule<br>* hard capsule orally QD: one dose lower than the highest dose level in part A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-inf | area under the plasma concentration-time curve of Lu AF28996 | From dosing to day 12 postdose | 
| Cmax | maximum observed plasma concentration of Lu AF28996 | From dosing to day 12 postdose | 
| CL/F | Oral clearance of Lu AF28996 | From dosing to day 12 postdose | 

Secondary 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 and ECG parameters) | From dosing to day 12 postdose |