Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women

Study Overview
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Brief Summary
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A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

Detailed Description
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Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences. For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.

Official Title
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Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AG06466
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has a BMI ≥18.5 and ≤30 kg/m2 The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding. Exclusion Criteria: The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19. 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: Lu AG06466 - Sequence 1<br>Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast. | Drug: Lu AG06466<br>* hard capsules, orally, single doses<br>Drug: Itraconazole<br>* 200 and 300 mg, capsules, orally<br>|
| Experimental: Lu AG06466 - Sequence 2<br>Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast. | Drug: Lu AG06466<br>* hard capsules, orally, single doses<br>Drug: Itraconazole<br>* 200 and 300 mg, capsules, orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC(0-inf) Lu AG06466 | Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 | 
| AUC(0-inf) Lu AG06988 | Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 | 
| Cmax Lu AG06466 | Maximum observed plasma concentration (Cmax) of Lu AG06466 | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 | 
| Cmax Lu AG06988 | Maximum observed plasma concentration (Cmax) of Lu AG06988 | From 0 to 48 hours post-dose on Day 1, 3, 8 and 10 |