Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants

NCT ID: NCT05177029

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-26
• Study Completion Date: 2021-12-29

Brief Summary

The main goal of this study is to evaluate the effect of Lu AG06466 on the body and what the body does to Lu AG06466 after single and multiple doses to healthy Japanese and Caucasian participants.

Detailed Description

This sequential study will be divided in two parts, Part A and Part B.

Part A will consist of 3 cohorts (Cohorts A1, A2, and A3) in which participants will be randomized to receive a single dose of Lu AG046466 or a matching placebo orally. After completing the safety review of data from Cohort A1, the study will proceed in Cohorts A2 and A3, with an increased dose of Lu AG046466 or matching placebo being administered to Japanese and Caucasian participants.

Part B dosing will only be initiated after completion of Part A. Part B will consist of 1 cohort (Cohort B1), to which multiple dose of Lu AG046466 or matching placebo will be administered after dose titration.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

Part A: Lu AG06466 or Placebo

Participants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1.

Group Type: EXPERIMENTAL

Lu AG06466

Intervention Type: DRUG

Lu AG06466 will be administered per schedule specified in the arm.

Placebo

Intervention Type: DRUG

Placebo matching to Lu AG06466 will be administered per schedule specified in the arm.

Part B: Lu AG06466 or Placebo

Participants will receive starting dose of Lu AG06466 capsule or matching placebo orally once daily from Day 1 to Day 4 followed by Lu AG06466 capsule or matching placebo at a titrated treatment dose orally once daily from Day 5 until Day 8. Participants will then receive LuAG06466 capsule or matching placebo at a higher assigned dose orally once daily from Day 9 to Day 15.

Group Type: EXPERIMENTAL

Lu AG06466

Intervention Type: DRUG

Lu AG06466 will be administered per schedule specified in the arm.

Placebo

Intervention Type: DRUG

Placebo matching to Lu AG06466 will be administered per schedule specified in the arm.

Interventions

Lu AG06466

Lu AG06466 will be administered per schedule specified in the arm.

Intervention Type: DRUG

Placebo

Placebo matching to Lu AG06466 will be administered per schedule specified in the arm.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant has a BMI ≥18.5 and ≤25 kilograms (kg)/square meter (m^2) or ≤30 kg/m^2 for Japanese and Caucasian participants, respectively, and a body weight ≥50 kilograms (kg) at the screening visit and at the baseline visit.
• The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, electrocardiograms (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria

• The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives of the disallowed medication as concomitant use prior to the screening visit.
• The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
• The participant has had a clinically significant illness <4 weeks prior to the first dose of study drug.
• The participant has received a SARS-CoV-2 (COVID-19) vaccination <30 days prior to the first dose of study drug.

• Minimum Eligible Age: 20 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

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

P-One Clinic, Keikokai Medical Corporation

Yokamachi Hachioji City, Tokyo, Japan

Countries

Japan

Other Identifiers

19891A

Identifier Type: -

Identifier Source: org_study_id