Safety and Tolerability of Lu AG06474 in Healthy Young Men

Phase 1

Waitlist Available

Research Sponsored by H. Lundbeck A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from pre-dose to day 4

Summary

This trial is testing a new drug called Lu AG06474 to see if it is safe and how well people can tolerate it. The study involves healthy volunteers or a general population to understand what happens to the drug in the body after swallowing it. The trial has two parts with different methods to ensure accurate results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from pre-dose to day 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from pre-dose to day 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose to day 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: t1/2 of Lu AG06474

Parts A and B: AUC0-inf of Lu AG06474

Parts A and B: Cmax of Lu AG06474

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Repeated Dose of Lu AG06474 and Food InteractionExperimental Treatment1 Intervention

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

Group II: Part A: Single Dose of Lu AG06474 or PlaceboExperimental Treatment2 Interventions

Participants will receive single oral dose of Lu AG06474 or placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Lu AG06474

2023