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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: Lu AG06474; Drug: Lu AG06474

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.

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Email contact via H. Lundbeck A/S; Phone Number: +45 36301311; Email: LundbeckClinicalTrials@Lundbeck.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Recruiting
      • Quotient Sciences Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Baseline Visit.
• The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
• The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

• The participant has previously been dosed with Lu AG06474.
• The participant has participated in a clinical trial <30 days prior to the Screening Visit.
• The participant has taken any investigational medicinal product ≥30 days or <5 half-lives of that product, whichever is longer, prior to the first dose of IMP.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Multiple Doses of Lu AG06474 or Placebo; Participants will receive multiple oral doses of Lu AG06474 or placebo.	Drug: Placebo; Oral Solution; Drug: Lu AG06474; Oral Solution; Drug: Lu AG06474; Capsule
Experimental: Part B: Single Doses of Lu AG06474; Participants will receive single oral doses of Lu AG06474.	Drug: Lu AG06474; Oral Solution; Drug: Lu AG06474; Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)	Up to Day 10
Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5	Day 5
Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval	Predose to Day 7
Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474	Predose to Day 6
Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax	Predose to Day 6
Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474	Predose to Day 6
Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity	Predose to Day 6
Part A: Accumulation Index	Predose to Day 7
Part B: Frel: Relative Bioavailability	Predose to Day 6

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): August 11, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20065A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No