Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated for strategic reasons.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lu AG06466 or Placebo | Experimental | Participants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1. |
|
| Part B: Lu AG06466 or Placebo | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 | Drug | Lu AG06466 will be administered per schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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-Ï„) | 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 | 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 | 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 | 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 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-One Clinic, Keikokai Medical Corporation | Yokamachi Hachioji City | Tokyo | 192-0071 | Japan |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo matching to Lu AG06466 will be administered per schedule specified in the arm. |
|
| 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 |
| 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 |