A Study Investigating Lu AG06474 in Healthy Young Participants

NCT ID: NCT05943327

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-28
• Study Completion Date: 2024-07-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: Multiple Doses of Lu AG06474 or Placebo

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

Group Type: EXPERIMENTAL

Lu AG06474

Intervention Type: DRUG

Oral Solution

Placebo

Intervention Type: DRUG

Oral Solution

Part B: Single Doses of Lu AG06474

Participants will receive single oral doses of Lu AG06474.

Group Type: EXPERIMENTAL

Lu AG06474

Intervention Type: DRUG

Oral Solution

Lu AG06474

Intervention Type: DRUG

Capsule

Interventions

Lu AG06474

Oral Solution

Intervention Type: DRUG

Placebo

Oral Solution

Intervention Type: DRUG

Lu AG06474

Capsule

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quotient Sciences Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20065A

Identifier Type: -

Identifier Source: org_study_id