Clinical trial NCT06337110: A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men
Official title: Interventional, Open-label, Single-dose Trial Investigating the Absorption, Metabolism, and Excretion (AME) of Lu AF28996 Following a Single Oral Dosing of 14C-Lu AF28996 to Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2024-03-29
Enrollment: 8
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)
timeFrame: From baseline (Day -1) up to 23 days post-dose
measure: AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: AUC0-infinity of Lu AF28996
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: Cmax of Lu AF28996
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: Tmax of Lu AF28996
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
measure: T½ of Lu AF28996
timeFrame: From date of dosing (Day 1) up to 23 days post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Fortrea Clinical Research Unit Ltd
Study officials:
References: