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

NCT06337110 | Completed Phase 1

• 1 other identifier: 20436A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Lu AF28996

EXPERIMENTAL

Participants will receive a single oral dose of Lu AF28996.

Drug: Lu AF28996

Interventions

Lu AF28996 DRUG

Oral solution containing radiolabelled \[14C\]-Lu AF28996.

Lu AF28996

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Fortrea Clinical Research Unit Ltd

Leeds, LS11 9EH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: April 10, 2024
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

GB (1)