Drug Drug Interaction Study With Lu AG06466 in Young Healthy Men

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of repeated doses of the drug Lu AG06466 on the exposure of metoprolol, midazolam and bupropion

Detailed Description
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On Day 1, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours. On Day 3, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours. On Days 5-18, subjects will be dosed with Lu AG06466 once daily. On Day 15, midazolam and metoprolol will be dosed as an oral single-dose cocktail and PK sampling will be performed for 48 hours. On Day 17, bupropion will be dosed as a single oral dose and PK sampling will be performed for 48 hours.

Official Title
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Interventional, Open-label, One-sequence Study to Investigate the Effects of Lu AG06466 on the Pharmacokinetics of the Cytochrome P450 Substrates Midazolam (CYP3A4), Bupropion (CYP2B6), and Metoprolol (CYP2D6) in Healthy Young Men and Women

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AG06466
* Other: Midazolam
* Other: Metoprolol
* Other: Bupropion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) of 18.5 to 30 kg/m2 (inclusive) at the Screening and Baseline Visits Exclusion Criteria: The subject has any concurrent disorder that may affect the pharmacological target or absorption, distribution, or elimination of the investigational medicinal product. 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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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
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AG06466<br> | Drug: Lu AG06466<br>* 10, 20, 30 mg/day oral capsules on Day 5-18<br>Other: Midazolam<br>* 4 mg syrup, oral single dose on Day 1 and Day 15<br>Other: Metoprolol<br>* 100 mg tablets, oral single dose on Day 1 and Day 15<br>Other: Bupropion<br>* 100 mg tablets, oral single dose on Day 3 and Day 17<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC 0-inf for midazolam | Area under the midazolam plasma concentration-time curve from zero to infinity | Day 1 and Day 15 | 
| AUC 0-inf for metoprolol | Area under the metoprolol plasma concentration-time curve from zero to infinity | Day 1 and Day 15 | 
| AUC 0-inf for bupropion | Area under the bupropion plasma concentration-time curve from zero to infinity | Day 3 and Day 17 | 
| Cmax for midazolam | Maximum observed plasma concentration for midazolam | Day 1 and Day 15 | 
| Cmax for metoprolol | Maximum observed plasma concentration for metoprolol | Day 1 and Day 15 | 
| Cmax for bupropion | Maximum observed plasma concentration for bupropion | Day 3 and Day 17 |