A Study Investigating Lu AG06466 in Healthy Men

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201092
• Other study ID #: 19960A
• Secondary ID: 2021-002048-54
• Status: Completed
• Phase: Phase 1
• Start date: January 5, 2022
• Est. completion date: February 19, 2022

Study information

• Verified date: March 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 19, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United Kingdom	LabCorp Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Percent Recovery of Radioactivity in Urine		From Day 1 to Day 23
Primary	Cumulative Percent Recovery of Radioactivity in Faeces		From Day 1 to Day 23
Primary	Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces		From Day 1 to Day 23
Primary	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
Primary	AUC0-inf of Metabolite Lu AG06988 in Plasma		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	Cmax of Metabolite Lu AG0988 in Plasma		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	Time to Reach Cmax (tmax) of Lu AG06466		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	Tmax of Metabolite Lu AG06988		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Primary	t1/2 of Metabolite Lu AG06988 in Plasma		0 (predose) up to 96 hours postdose on Day 1 to Day 5