NCT05943327

A Study Investigating Lu AG06474 in Healthy Young Participants

Interventional, Randomized, Double-blind, Sequential Cohort, Placebo-controlled, Multiple-dose Trial Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 in Healthy Young Men and Women, With an Open-label, Cross-over, Single-dose Part Investigating the Relative Bioavailability of a Capsule Formulation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.

Detailed description

The study has 2 parts: Part A and Part B. Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo. Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Lu AG06474	Oral Solution
DRUG	Placebo	Oral Solution
DRUG	Lu AG06474	Capsule

Timeline

• Start date: 2023-06-28
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2023-07-13
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study