A Study Investigating Lu AG06474 in Healthy Young Participants

Lundbeck

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: Lu AG06474

Study type: Interventional

Funder types: Industry

Identifiers

NCT05943327

20065A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

---

56 participants in 2 patient groups

Part A: Multiple Doses of Lu AG06474 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Lu AG06474

Drug: Placebo

Drug: Lu AG06474

Part B: Single Doses of Lu AG06474

Experimental group

Description:

Participants will receive single oral doses of Lu AG06474.

Treatment:

Drug: Lu AG06474

Drug: Lu AG06474