Healthy VolunteersPhase 1NCT05201092
A Study Investigating Lu AG06466 in Healthy Men
A Phase 1 study testing [14C]-Lu AG06466 in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C]-Lu AG06466
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2022to 19 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- [14C]-Lu AG06466
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-Lu AG06466Drug
[14C]-Lu AG06466 will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-Lu AG06466 | Experimental | Participants will receive a single oral dose of [14C]-Lu AG06466 on Day 1 in the fed state. Receives: Drug: [14C]-Lu AG06466 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Percent Recovery of Radioactivity in Urine
Measured: From Day 1 to Day 23
Cumulative Percent Recovery of Radioactivity in Faeces
Measured: From Day 1 to Day 23
Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces
Measured: From Day 1 to Day 23
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AG06466
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
AUC0-inf of Metabolite Lu AG06988 in Plasma
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Cmax of Metabolite Lu AG0988 in Plasma
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Time to Reach Cmax (tmax) of Lu AG06466
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Tmax of Metabolite Lu AG06988
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Apparent Elimination Half-life (t1/2) of Lu AG06466 in Plasma
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
t1/2 of Metabolite Lu AG06988 in Plasma
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start5 Jan 2022
- Primary completion19 Feb 2022
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201092
- Sponsor's protocol ID
- 19960A
- Other IDs
- 2021-002048-54
- Status last verified
- Mar 2022
- First submitted
- 7 Jan 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05201092
- Acronym / sponsor ID
- 19960A
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-Lu AG06466 | Experimental | Drug: [14C]-Lu AG06466Participants will receive a single oral dose of [14C]-Lu AG06466 on Day 1 in the fed state. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-Lu AG06466[14C]-Lu AG06466 will be administered per schedule specified in the arm description. | Drug | [14C]-Lu AG06466 |
Primary outcome
Cumulative Percent Recovery of Radioactivity in Urine
Time frame: From Day 1 to Day 23
Cumulative Percent Recovery of Radioactivity in Faeces
Time frame: From Day 1 to Day 23
Total Cumulative Percent Recovery of Radioactivity in Urine and Faeces
Time frame: From Day 1 to Day 23
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
AUC0-inf of Metabolite Lu AG06988 in Plasma
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Maximum Observed Concentration (Cmax) of Lu AG06466 in Plasma
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Cmax of Metabolite Lu AG0988 in Plasma
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Time to Reach Cmax (tmax) of Lu AG06466
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Tmax of Metabolite Lu AG06988
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
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
t1/2 of Metabolite Lu AG06988 in Plasma
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-Lu AG06466 in people with Healthy Volunteers, run by H. Lundbeck A/S at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Percent Recovery of Radioactivity in Urine (time frame: From Day 1 to Day 23). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.