Healthy
Conditions
Brief summary
The purpose of this study is to investigate the safety and tolerability of Lu AG06474 and what the body does to Lu AG06474 after swallowing single doses of the drug.
Detailed description
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Interventions
DRUGLu AG06474
solution, orally (Parts A and B)
DRUGPlacebo
solution, orally (Part A only)
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Part A: randomized, double-blind, sequential. Part B: randomized, open-label, cross-over.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m\^2) at the Screening Visit and at the Safety Baseline/Baseline Visit. * The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, a safety 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 prior to the Screening Visit for any medication taken. * The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 millimeters of mercury (mmHg) and/or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Safety Baseline/Baseline Visit. * The participant has a QTcF interval \>450 milliseconds (ms) at the Screening Visit or at the Safety Baseline/Baseline Visit, as calculated by the ECG equipment and evaluated by the investigator. * The participant has taken any investigational medicinal product \<3 months prior to the first dose of study drug. * The participant has received an injection of COVID-19 vaccination less than 30 days prior to the first dose of study drug. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Number of participants With Treatment-Emergent Adverse Events | From Baseline to Day 8 | — |
| Part A: Electrocardiogram (ECG) Parameter (Delta QTcF) at 24 Hours on Day 1 | Day 1 | — |
| Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1 | Pre-dose Baseline (Day -1), Day 1 | — |
| Part A: Bond-Lader VAS Dimension Scores at Day 4 | Day 4 | — |
| Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4 | Pre-dose Baseline (Day -1), Day 4 | — |
| Part A: Percentage of Peripheral Blood Mononuclear Cells (PBMC)-Mediated Hydrolysis of 2-arachidonolylglycerol (2-AG) Ex Vivo (% of Pre-Dose Measurement of Arachidonic Acid [AA]) | From pre-dose to Day 4 | — |
| Parts A and B: AUC0-inf of Lu AG06474 | From pre-dose to Day 4 | Area under the Lu AG06474 concentration-time curve from time zero to infinity (AUC0-inf) |
| Parts A and B: Cmax of Lu AG06474 | From pre-dose to Day 4 | Maximum observed plasma concentration for Lu AG06474 |
| Parts A and B: Tmax of Lu AG06474 | From pre-dose to Day 4 | Nominal time corresponding to the occurrence of Cmax of Lu AG06474 |
| Part A: t1/2 of Lu AG06474 | From pre-dose to Day 4 | Apparent elimination half-life of Lu AG06474 |
Countries
United States
Outcome results
None listed