A Study Investigating Lu AG06466 in Healthy Men

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-Lu AG06466

• Registration Number: NCT05201092
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2022-01-05
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-01-21
• Primary Completion: 2022-02-19
• Study Completion: 2022-02-19
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative Percent Recovery of Radioactivity in Urine	From Day 1 to Day 23
Cumulative Percent Recovery of Radioactivity in Faeces	From Day 1 to Day 23
Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces	From Day 1 to Day 23
AUC0-inf of Metabolite Lu AG06988 in Plasma	0 (predose) up to 96 hours postdose on Day 1 to Day 5
Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma	0 (predose) up to 96 hours postdose on Day 1 to Day 5
Cmax of Metabolite Lu AG0988 in Plasma	0 (predose) up to 96 hours postdose on Day 1 to Day 5
Time to Reach Cmax (tmax) of Lu AG06466	0 (predose) up to 96 hours postdose on Day 1 to Day 5
Tmax of Metabolite Lu AG06988	0 (predose) up to 96 hours postdose on Day 1 to Day 5
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AG06466	0 (predose) up to 96 hours postdose on Day 1 to Day 5
Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma	0 (predose) up to 96 hours postdose on Day 1 to Day 5
t1/2 of Metabolite Lu AG06988 in Plasma	0 (predose) up to 96 hours postdose on Day 1 to Day 5

Trial Locations

Locations (1)

LabCorp Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom