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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: Lu AG06466; Drug: Placebo

• Registration Number: NCT05177029
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2021-11-26
• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Primary Completion: 2021-12-29
• Study Completion: 2021-12-29
• Study First Posted: 2022-01-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part A: Lu AG06466 or Placebo	Lu AG06466	Participants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1.
Part A: Lu AG06466 or Placebo	Placebo	Participants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1.
Part B: Lu AG06466 or Placebo	Lu AG06466	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.
Part B: Lu AG06466 or Placebo	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.

Primary Outcome Measures

Name	Time	Method
Part A: Number of Participants With Adverse Events	Baseline up to Day 12
Part B: Number of Participants With Adverse Events	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)	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)	0 (pre-dose) up to 24 hours post-dose on Day 15
Part B: Cmax of Lu AG06466 and Metabolite Lu AG06988	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	0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Part A: Metabolic Ratio of AUC0-inf (MRAUC0-inf): AUC0-inf, Lu AG06988/AUC0-inf, Lu AG06466	0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Part A: Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 and Metabolite Lu AG06988	0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Part A: Nominal Time Corresponding to the Occurrence of Cmax (Tmax) of Lu AG06466 and Metabolite Lu AG06988	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	0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15
Part B: t1/2 of Lu AG06466 and Metabolite Lu AG06988	0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 17

Trial Locations

Locations (1)

P-One Clinic, Keikokai Medical Corporation; 🇯🇵 Yokamachi Hachioji City, Tokyo, Japan