Study Investigating the Safety and Tolerability of Lu AF88434 in Healthy Young Men

Study Overview
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Brief Summary
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This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses

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 AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF88434
* Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
* Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
* 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) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit and Baseline 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. For Part B: The subject has received radiolabelled material <12 months prior to the Screening Visit. 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A Lu AF88434 or Placebo<br>6 cohorts (cohort A1 to A6) with 9 subjects in each cohort. In each cohort 6 subjects will receive single doses of Lu AF88434 and 3 subjects will receive placebo | Drug: Lu AF88434<br>* Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).<br>Drug: Placebo<br>* Placebo to Lu AF88434 oral solution, single dose<br>|
| Experimental: Part B1 Lu AF88434 Fed-Fasting-Fasting<br>4 subjects will receive an identical oral dose of Lu AF88434 in Group B1. The treatment sequence for Group B1 is: Fed-Fasting-Fasting. 14C-spiked dose (Lu AF99723) will be given in the last treatment sequence. | Drug: Lu AF88434<br>* Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).<br>Drug: Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)<br>* Oral solution<br>|
| Experimental: Part B2 Lu AF88434 Fasting-Fed-Fasting<br>4 subjects will receive an identical oral dose of Lu AF88434 in Group B2. The treatment sequence for Group B2 is: Fasting-Fed-Fasting. 14C-spiked dose (Lu AF99722) will be given in the last treatment sequence. | Drug: Lu AF88434<br>* Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).<br>Drug: Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)<br>* Oral solution<br>|
| Experimental: Part B3 Lu AF88434 Fasting-Fasting-Fed<br>4 subjects will receive an identical oral dose of Lu AF88434 in Group B3. The treatment sequence for Group B3 is: Fasting-Fasting-Fed. | Drug: Lu AF88434<br>* Lu AF88434, single oral solution Starting dose will be 0.2 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) | From screening to Day 11 | 
| Cmax Lu AF88434 | Maximum observed plasma concentration | From 0 to 96 hours | 
| AUC(0-inf) Lu AF88434 | Area under the plasma concentration time curve from zero to infinity | From 0 to 96 hours | 
| CL/F Lu AF88434 | Oral clearance for Lu AF88434 in plasma | From day 1 to day 5 | 
| Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) |  | From 0 to Day 14 | 
| Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose) |  | From 0 to Day 14 |