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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Lu AF28996

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Email contact via H. Lundbeck A/S; Phone Number: +45 36301311; Email: LundbeckClinicalTrials@Lundbeck.com

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS11 9EH
    • Recruiting
    • Fortrea Clinical Research Unit Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AF28996; Participants will receive a single oral dose of Lu AF28996.	Drug: Lu AF28996; Oral solution containing radiolabelled [14C]-Lu AF28996.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): May 25, 2024
• Study Completion (Estimated): May 25, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20436A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No