Healthy ParticipantsPhase 1NCT06337110
A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men
A Phase 1 study testing Lu AF28996 in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in United Kingdom.
Trial summary
The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants. Read more about this study
- Who is it for?
- Ages 35 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lu AF28996
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2024to 11 May 2024
- 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 35 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 per square meter (kg/m^2) and body weight ≥60 kg at the Screening Visit and at the Baseline Visit.
- The participant has a resting supine pulse >=50 and <=100 beats per minute (bpm) 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, a 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 participated in a clinical trial <30 days prior to the Screening Visit.
- The participant has taken any investigational medicinal product <3 months or <5 half-lives of that product, whichever is longest, prior to the first dose of investigational medicinal product (IMP).
- Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Other protocol-defined criteria apply.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Fortrea Clinical Research Unit Ltd
Leeds, LS11 9EH
About this study
Official title: Interventional, Open-label, Single-dose Trial Investigating the Absorption, Metabolism, and Excretion (AME) of Lu AF28996 Following a Single Oral Dosing of 14C-Lu AF28996 to Healthy Men
The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.
- Conditions
- Healthy Participants
- Being tested
- Lu AF28996
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF28996Drug
Oral solution containing radiolabelled [14C]-Lu AF28996.
| Study group | Role | What they receive |
|---|---|---|
| Lu AF28996 | Experimental | Participants will receive a single oral dose of Lu AF28996. Receives: Drug: Lu AF28996 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)
Measured: From baseline (Day -1) up to 23 days post-dose
AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity
Measured: From date of dosing (Day 1) up to 23 days post-dose
Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material
Measured: From date of dosing (Day 1) up to 23 days post-dose
Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material
Measured: From date of dosing (Day 1) up to 23 days post-dose
T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material
Measured: From date of dosing (Day 1) up to 23 days post-dose
AUC0-infinity of Lu AF28996
Measured: From date of dosing (Day 1) up to 23 days post-dose
Cmax of Lu AF28996
Measured: From date of dosing (Day 1) up to 23 days post-dose
Tmax of Lu AF28996
Measured: From date of dosing (Day 1) up to 23 days post-dose
T½ of Lu AF28996
Measured: From date of dosing (Day 1) up to 23 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start10 Apr 2024
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 8 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
- NCT06337110
- Sponsor's protocol ID
- 20436A
- Status last verified
- Oct 2024
- First submitted
- 22 Mar 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Single-dose Trial Investigating the Absorption, Metabolism, and Excretion (AME) of Lu AF28996 Following a Single Oral Dosing of 14C-Lu AF28996 to Healthy Men
- ClinicalTrials.gov ID
- NCT06337110
- Acronym / sponsor ID
- 20436A
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 29 Mar 2024 (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 main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu AF28996 | Experimental | Drug: Lu AF28996Participants will receive a single oral dose of Lu AF28996. |
Who may qualify
- Ages
- 35 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 per square meter (kg/m^2) and body weight ≥60 kg at the Screening Visit and at the Baseline Visit.
- The participant has a resting supine pulse >=50 and <=100 beats per minute (bpm) 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, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (4 listed)
- The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- The participant has taken any investigational medicinal product <3 months or <5 half-lives of that product, whichever is longest, prior to the first dose of investigational medicinal product (IMP).
- Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Other protocol-defined criteria apply.
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 |
|---|---|---|
| Lu AF28996Oral solution containing radiolabelled [14C]-Lu AF28996. | Drug | Lu AF28996 |
Primary outcome
Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces)
Time frame: From baseline (Day -1) up to 23 days post-dose
AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity
Time frame: From date of dosing (Day 1) up to 23 days post-dose
Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material
Time frame: From date of dosing (Day 1) up to 23 days post-dose
Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material
Time frame: From date of dosing (Day 1) up to 23 days post-dose
T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material
Time frame: From date of dosing (Day 1) up to 23 days post-dose
AUC0-infinity of Lu AF28996
Time frame: From date of dosing (Day 1) up to 23 days post-dose
Cmax of Lu AF28996
Time frame: From date of dosing (Day 1) up to 23 days post-dose
Tmax of Lu AF28996
Time frame: From date of dosing (Day 1) up to 23 days post-dose
T½ of Lu AF28996
Time frame: From date of dosing (Day 1) up to 23 days post-dose
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 4 Oct 2024.
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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 Lu AF28996 in people with Healthy Participants, 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 4 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 4 Oct 2024. 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?
Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces) (time frame: From baseline (Day -1) up to 23 days post-dose). The study lists 9 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 4 Oct 2024.