A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

Study Overview
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Brief Summary
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The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.

Detailed Description
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This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.

Official Title
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Interventional, Randomized, Open-Label, Crossover, Single-Dose, Relative Bioavailability Study Comparing Two Pharmaceutical Formulations of Lu AG06466 and Investigating the Food Effect on Lu AG06466 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AG06466 Capsule
* Drug: Lu AG06466 Tablet
* Drug: Antacid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m^2 at the Screening Visit and at the Baseline Visit. The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit. Exclusion Criteria: The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses). The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. Other inclusion 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: Crossover Assignment
Interventional Model Description: The first 3 periods will be randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AG06466 Capsule, Fasted State<br>Participants will receive 1 capsule of Lu AG06466 in a fasted state. | Drug: Lu AG06466 Capsule<br>* Hard capsule<br>|
| Experimental: Lu AG06466 Tablet, Fasted State<br>Participants will receive 1 tablet of Lu AG06466 in a fasted state. | Drug: Lu AG06466 Tablet<br>* Film-coated tablet<br>|
| Experimental: Lu AG06466 Tablet, Fed State<br>Participants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal). | Drug: Lu AG06466 Tablet<br>* Film-coated tablet<br>|
| Experimental: Lu AG06466 Tablet + Antacid, Fasted State<br>Participants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state. | Drug: Lu AG06466 Tablet<br>* Film-coated tablet<br>Drug: Antacid<br>* Oral suspension<br>* Other names: Aluminum hydroxide and magnesium hydroxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466 | AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life). | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| AUC(0-inf) of Metabolite Lu AG06988 | AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life). | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| AUC0-tlast of Metabolite Lu AG06988 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Cmax of Metabolite Lu AG06988 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Time to Reach Cmax (Tmax) of Lu AG06466 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Tmax of Metabolite Lu AG06988 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Apparent Oral Clearance (CL/F) of Lu AG06466 | CL/F is defined as dose / AUC0-inf. | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Apparent Volume of Distribution (Vz/F) of Lu AG06466 | Vz/F is defined as CL/F * t1/2 / ln2. | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Apparent Elimination Half-life (t1/2) of Lu AG06466 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| t1/2 of Metabolite Lu AG06988 |  | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | 
| Metabolic Ratio (MR) | MR is defined as AUC0-inf, Lu AG06988 / AUC0-inf, Lu AG06466. | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |