A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men
- Registration Number
- NCT06337110
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lu AF28996 Lu AF28996 Participants will receive a single oral dose of Lu AF28996.
- Primary Outcome Measures
Name Time Method 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 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 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 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 Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material From date of dosing (Day 1) up to 23 days post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Ltd
🇬🇧Leeds, United Kingdom