A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337110
• Other study ID #: 20436A
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2024
• Est. completion date: May 25, 2024

Study information

• Verified date: May 2024
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: May 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lu AF28996
Oral solution containing radiolabelled [14C]-Lu AF28996.

Locations

Country	Name	City	State
United Kingdom	Fortrea Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material		From date of dosing (Day 1) up to 23 days post-dose
Primary	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
Primary	T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material		From date of dosing (Day 1) up to 23 days post-dose
Primary	AUC0-infinity of Lu AF28996		From date of dosing (Day 1) up to 23 days post-dose
Primary	Cmax of Lu AF28996		From date of dosing (Day 1) up to 23 days post-dose
Primary	Tmax of Lu AF28996		From date of dosing (Day 1) up to 23 days post-dose
Primary	T½ of Lu AF28996		From date of dosing (Day 1) up to 23 days post-dose