Clinical trial NCT05177029: Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants
Official title: Interventional, Randomized, Double-Blind, Sequential-Part, Placebo-Controlled, Single- and Multiple-Dose Study Investigating Safety, Tolerability, and Pharmacokinetic Properties of Lu AG06466 in Healthy Young Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Part A: Number of Participants With Adverse Events
timeFrame: Baseline up to Day 12
measure: Part B: Number of Participants With Adverse Events
timeFrame: Baseline up to Day 26
measure: Part A: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 From Zero to Infinity (AUC0-inf)
timeFrame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
measure: Part B: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 in a Dosing Interval (AUC0-τ)
timeFrame: 0 (pre-dose) up to 24 hours post-dose on Day 15
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 and Metabolite Lu AG06988
timeFrame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
measure: Part B: Cmax of Lu AG06466 and Metabolite Lu AG06988
timeFrame: 0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15
measure: Part A: Nominal Time Corresponding to the Occurrence of Cmax (Tmax) of Lu AG06466 and Metabolite Lu AG06988
timeFrame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
measure: Part B: Tmax of Lu AG06466 and Metabolite Lu AG06988
timeFrame: 0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15
measure: Part A: Apparent Elimination Half-Life (t1/2) of Lu AG06466 and Metabolite Lu AG06988
timeFrame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
measure: Part B: t1/2 of Lu AG06466 and Metabolite Lu AG06988
timeFrame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 17
measure: Part A: Metabolic Ratio of AUC0-inf (MRAUC0-inf): AUC0-inf, Lu AG06988/AUC0-inf, Lu AG06466
timeFrame: 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Yokamachi Hachioji City
country: Japan
facility: P-One Clinic, Keikokai Medical Corporation
state: Tokyo
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: