Safety and Tolerability of Lu AG06474 in Healthy Young Men

Recruitment & Eligibility

Inclusion Criteria

The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) at the Screening Visit and at the Safety Baseline/Baseline Visit.
The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria

The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmHg) and/or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Safety Baseline/Baseline Visit.
The participant has a QTcF interval >450 milliseconds (ms) at the Screening Visit or at the Safety Baseline/Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator.
The participant has taken any investigational medicinal product <3 months prior to the first dose of study drug.
The participant has received an injection of COVID-19 vaccination less than 30 days prior to the first dose of study drug.

Other inclusion and exclusion criteria may apply.

Study & Design

Arm && Interventions

Group	Intervention	Description
Part A: Single Dose of Lu AG06474 or Placebo	Placebo	Participants will receive single oral dose of Lu AG06474 or placebo.
Part A: Single Dose of Lu AG06474 or Placebo	Lu AG06474	Participants will receive single oral dose of Lu AG06474 or placebo.
Part B: Repeated Dose of Lu AG06474 and Food Interaction	Lu AG06474	Participants will receive a single oral dose of Lu AG06474 in each dosing period (Period 1, 2, and 3) in the following sequence: Sequence B1: Fed - Fasting- Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed

Primary Outcome Measures

Name	Time	Method
Parts A and B: Number of participants With Treatment-Emergent Adverse Events	From Baseline to Day 8
Parts A and B: Cmax of Lu AG06474	From pre-dose to Day 4	Maximum observed plasma concentration for Lu AG06474
Parts A and B: Tmax of Lu AG06474	From pre-dose to Day 4	Nominal time corresponding to the occurrence of Cmax of Lu AG06474
Part A: t1/2 of Lu AG06474	From pre-dose to Day 4	Apparent elimination half-life of Lu AG06474
Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1	Pre-dose Baseline (Day -1), Day 1
Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1	Day 1
Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4	Pre-dose Baseline (Day -1), Day 4
Part A: Bond-Lader VAS Dimension Scores at Day 4	Day 4
Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA])	From pre-dose to Day 4
Parts A and B: AUC0-inf of Lu AG06474	From pre-dose to Day 4	Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf)

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility