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

Phase 1TerminatedNCT05177029

H. Lundbeck A/S24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

Lu AG06466DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Note: Other inclusion and exclusion criteria may apply.

Locations (1)

P-One Clinic, Keikokai Medical Corporation

Yokamachi Hachioji City, Tokyo, Japan

Outcomes

Primary Outcomes

Part A: Number of Participants With Adverse Events

Time frame: Baseline up to Day 12

Part B: Number of Participants With Adverse Events

Time frame: Baseline up to Day 26

Part A: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 From Zero to Infinity (AUC0-inf)

Time frame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

Part B: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 in a Dosing Interval (AUC0-τ)

Time frame: 0 (pre-dose) up to 24 hours post-dose on Day 15

Part A: Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 and Metabolite Lu AG06988

Time frame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

Part B: Cmax of Lu AG06466 and Metabolite Lu AG06988

Time frame: 0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15

Part A: Nominal Time Corresponding to the Occurrence of Cmax (Tmax) of Lu AG06466 and Metabolite Lu AG06988

Time frame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

Part B: Tmax of Lu AG06466 and Metabolite Lu AG06988

Time frame: 0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15

Part A: Apparent Elimination Half-Life (t1/2) of Lu AG06466 and Metabolite Lu AG06988

Time frame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

Part B: t1/2 of Lu AG06466 and Metabolite Lu AG06988

Data from ClinicalTrials.gov

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