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TerminatedNCT05943327Updated Nov 18, 2024

A Study Investigating Lu AG06474 in Healthy Young Participants

A Phase 1 interventional study of Lu AG06474 and Placebo in Healthy Participants, sponsored by H. Lundbeck A/S. Terminated at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment

Why this study was terminated
For strategic reasons

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Part A: Multiple Doses of Lu AG06474 or Placebo

    Participants will receive multiple oral doses of Lu AG06474 or placebo.

    Drug: Lu AG06474 · Drug: Placebo

  • Experimental
    Part B: Single Doses of Lu AG06474

    Participants will receive single oral doses of Lu AG06474.

    Drug: Lu AG06474

Interventions

  • DrugLu AG06474

    Oral Solution

  • DrugPlacebo

    Oral Solution

  • DrugLu AG06474

    Capsule

06

What researchers measure

Primary outcomes

  1. Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)

    Time frame: Up to Day 10

  2. Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5

    Time frame: Day 5

  3. Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval

    Time frame: Predose to Day 7

  4. Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474

    Time frame: Predose to Day 6

  5. Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax

    Time frame: Predose to Day 6

  6. Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474

    Time frame: Predose to Day 6

  7. Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity

    Time frame: Predose to Day 6

  8. Part A: Accumulation Index

    Time frame: Predose to Day 7

  9. Part B: Frel: Relative Bioavailability

    Time frame: Predose to Day 6

07

Study locations

1 site
  • Quotient Sciences Miami
    Miami, Florida 33126, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05943327
Lead sponsor
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Jul 13, 2023
Start date
Jun 28, 2023
Primary completion
Jul 19, 2024
Completion
Jul 19, 2024
Last update
Nov 18, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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