Clinical trial NCT05201092: A Study Investigating Lu AG06466 in Healthy Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 6
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Cumulative Percent Recovery of Radioactivity in Urine
timeFrame: From Day 1 to Day 23
measure: Cumulative Percent Recovery of Radioactivity in Faeces
timeFrame: From Day 1 to Day 23
measure: Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces
timeFrame: From Day 1 to Day 23
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AG06466
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: AUC0-inf of Metabolite Lu AG06988 in Plasma
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: Cmax of Metabolite Lu AG0988 in Plasma
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: Time to Reach Cmax (tmax) of Lu AG06466
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: Tmax of Metabolite Lu AG06988
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
measure: t1/2 of Metabolite Lu AG06988 in Plasma
timeFrame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: LabCorp Clinical Research Unit Ltd
Study officials:
References: