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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210465

Enrollment

Registered

2021-12-03

Start date

2021-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropsychiatric symptoms for which enhanced signaling of the endocannabinoid system (ECS) and 2-ara

Interventions

Part A: Participants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1. Part B: Participants will receive starting dose of Lu AG06466 capsule or matching placebo orall

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -The participant has a BMI >= 18.5 and =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

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.

Design outcomes

Primary

Measure	Time frame
- Part A: Number of Participants With Adverse Events from Baseline up to Day 12 - Part B: Number of Participants With Adverse Events from 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) from 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-tau) from 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 from 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 from 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 from 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 from 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 AG0646 and Metabolite Lu AG06988 from 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3 - Part B: t1/2 of Lu AG0646 and Metabolite Lu AG06988 from 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 17 Part A: Metabolic Ratio of AUC0-inf (MRAUC0-inf): AUC0-inf, Lu AG06988/AUC0-inf, Lu AG06466 from 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3	—

Measure

Time frame

- Part A: Number of Participants With Adverse Events from Baseline up to Day 12 - Part B: Number of Participants With Adverse Events from 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) from 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-tau) from 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 from 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 from 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 from 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 from 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 AG0646 and Metabolite Lu AG06988 from 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3 - Part B: t1/2 of Lu AG0646 and Metabolite Lu AG06988 from 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 17 Part A: Metabolic Ratio of AUC0-inf (MRAUC0-inf): AUC0-inf, Lu AG06988/AUC0-inf, Lu AG06466 from 0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3

—

Contacts

Public ContactAtsuhiro Mizuno

PPD-SNBL K.K.

Atsuhiro.Mizuno@ppd.com+81-3-6821-0802

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026