A Study Investigating Lu AG06466 in Healthy Men

NCT ID: NCT05201092

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-05
• Study Completion Date: 2022-02-19

Brief Summary

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.

Detailed Description

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

[14C]-Lu AG06466

Participants will receive a single oral dose of \[14C\]-Lu AG06466 on Day 1 in the fed state.

Group Type: EXPERIMENTAL

[14C]-Lu AG06466

Intervention Type: DRUG

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

Interventions

[14C]-Lu AG06466

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LabCorp Clinical Research Unit Ltd

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

2021-002048-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19960A

Identifier Type: -

Identifier Source: org_study_id