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Completed

NCT Number: NCT05201092

A Study Investigating Lu AG06466 in Healthy Men

The purpose of this study is to investigate how the drug Lu AG06466 is absorbed, metabolized, and excreted from the body, for example, what the body does to the drug after swallowing a single dose.

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Key information

Conditions

Healthy Volunteers

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

LabCorp Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

About this study

Researchers will measure the levels of the drug and its breakdown product in each participants blood for up to 5 days after dosing. Radioactivity in urine and feces will be measured for up to 3.5 weeks after dosing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)/square meter (m^2) and a body weight of ≥60 kg at the Screening Visit and at the Baseline Visit.
  • The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg 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, neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion criteria

  • The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives prior to the Screening Visit for any medication taken.
  • The participant has orthostatic hypotension, defined as a decrease in systolic blood pressure ≥20 mmHg or a decrease in diastolic blood pressure ≥10 mmHg from supine to standing, at the Screening Visit or at the Baseline Visit.
  • The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
  • The participant has received a COVID-19 vaccination less than 30 days prior to the first dose of study drug.
  • The participant trains/exercises intensively, for example, for a marathon or triathlon, or at a competitive level.
  • The participant is exposed to significant levels of ionizing radiation at work.
  • The participant has undergone any clinical procedures involving significant exposure to radiation (excluding dental X-ray and common X-rays of the chest or extremities) <12 months prior to the Screening Visit.
  • The participant has received radiolabelled material <12 months prior to the Screening Visit.

Note: Other inclusion and exclusion criteria may apply.

Treatment and study plan

[14C]-Lu AG06466

Drug

[14C]-Lu AG06466 will be administered per schedule specified in the arm description.

Primary outcomes

  1. Cumulative Percent Recovery of Radioactivity in Urine

    Time frame: From Day 1 to Day 23

  2. Cumulative Percent Recovery of Radioactivity in Faeces

    Time frame: From Day 1 to Day 23

  3. Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces

    Time frame: From Day 1 to Day 23

  4. Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AG06466

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  5. AUC0-inf of Metabolite Lu AG06988 in Plasma

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  6. Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  7. Cmax of Metabolite Lu AG0988 in Plasma

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  8. Time to Reach Cmax (tmax) of Lu AG06466

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  9. Tmax of Metabolite Lu AG06988

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  10. Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

  11. t1/2 of Metabolite Lu AG06988 in Plasma

    Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-Label, Single-Dose Study Investigating the Absorption, Metabolism and Excretion (AME) of Lu AG06466 Following Oral Dosing of 14C-Lu AG06466 to Healthy Men

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Mar 16, 2022

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.

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