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 purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.
Part A: randomized, sequential
Part B: open-label, cross-over
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single dose of Lu AG06479 or Placebo | Experimental |
| |
| Part B: Repeated dose of Lu AG06479 and Food interaction | Experimental | Sequence B1: Fed - Fasting - Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06479 | Drug | capsules, orally (Part A and B) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (Safety and Tolerability) | Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters) | From baseline to Day 9 (Part A and B) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-inf) of Lu AG06479 | Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf) | From pre-dose to Day 5 (Part A and B) |
| CL/F Lu AG06479 | Oral clearance of Lu AG06479 |
Not provided
Inclusion Criteria:
Other in- 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 | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Madison | Wisconsin | 53704 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebos | Drug | Placebo - capsules, orally (Part A only) |
|
| From pre-dose to Day 5 (Part A and B) |
| Cmax Lu AG06479 | Maximum observed plasma concentration for Lu AG06479 | From pre-dose to Day 5 (Part A and B) |