A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

Detailed Description
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This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.

Official Title
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Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF11167
* Drug: [14C]-Lu AF11167
* Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2 (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status Exclusion Criteria: The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product Other in- and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br> | Drug: Lu AF11167<br>* Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)<br>|
| Experimental: Part B group 1<br>Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal | Drug: [14C]-Lu AF11167<br>* single iv microdose administered as a 15 minutes infusion<br>Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)<br>* Single oral dose<br>|
| Experimental: Part B group 2<br>Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted | Drug: [14C]-Lu AF11167<br>* single iv microdose administered as a 15 minutes infusion<br>Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)<br>* Single oral dose<br>|
| Experimental: Part B group 3<br>Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv | Drug: [14C]-Lu AF11167<br>* single iv microdose administered as a 15 minutes infusion<br>Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)<br>* Single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of Lu AF11167 | Maximum observed plasma concentration | From 0 to 48 hours | 
| AUC(0-inf) of Lu AF11167 | Area under the plasma concentration time curve from zero to infinity | From 0 to 48 hours | 
| Relative bioavailability F(rel) of Lu AF11167 | F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only) | From 0 to 48 hours | 
| Absolute bioavailability F(abs) of Lu AF11167 | F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only) | From 0 to 48 hours |