Healthy Participants
Conditions
Brief summary
The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.
Interventions
DRUGLu AF28996
Oral solution containing radiolabelled \[14C\]-Lu AF28996.
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * The participant has a Body Mass Index (BMI) \>=18.5 and \<=30 kilograms per square meter (kg/m\^2) and body weight ≥60 kg at the Screening Visit and at the Baseline Visit. * The participant has a resting supine pulse \>=50 and \<=100 beats per minute (bpm) 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, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests. Key
Exclusion criteria
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit. * The participant has taken any investigational medicinal product \<3 months or \<5 half-lives of that product, whichever is longest, prior to the first dose of investigational medicinal product (IMP). * Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in. Other protocol-defined criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces) | From baseline (Day -1) up to 23 days post-dose |
| AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity | From date of dosing (Day 1) up to 23 days post-dose |
| Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material | From date of dosing (Day 1) up to 23 days post-dose |
| Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material | From date of dosing (Day 1) up to 23 days post-dose |
| T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material | From date of dosing (Day 1) up to 23 days post-dose |
| AUC0-infinity of Lu AF28996 | From date of dosing (Day 1) up to 23 days post-dose |
| Cmax of Lu AF28996 | From date of dosing (Day 1) up to 23 days post-dose |
| Tmax of Lu AF28996 | From date of dosing (Day 1) up to 23 days post-dose |
| T½ of Lu AF28996 | From date of dosing (Day 1) up to 23 days post-dose |
Countries
United Kingdom
Outcome results
None listed