Skip to main content
OpenTrials
Completed

NCT Number: NCT06337110

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

35 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Ltd

Leeds, LS11 9EH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF28996

Drug

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

Primary outcomes

  1. Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)

    Time frame: From baseline (Day -1) up to 23 days post-dose

  2. AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  3. Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  4. Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  5. T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  6. AUC0-infinity of Lu AF28996

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  7. Cmax of Lu AF28996

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  8. Tmax of Lu AF28996

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

  9. T½ of Lu AF28996

    Time frame: From date of dosing (Day 1) up to 23 days post-dose

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.