Healthy ParticipantsPhase 1NCT06077786
A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants
A Phase 1 study testing Lu AG06474, Ibuprofen and Pregabalin in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in Netherlands.
Trial summary
The main goal of this trial is to learn about the effect of Lu AG06474 on a battery of Evoked Pain Tests when a single dose is given to healthy adult participants. The effects of Lu AG06474 will be compared with 2 approved pain-relieving medications (ibuprofen and pregabalin) and with a placebo (a treatment that looks… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lu AG06474, Ibuprofen and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Oct 2023to 17 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant has a body mass index (BMI) ≥18.5 and ≤32 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Trial 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 ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Who cannot join
- The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
- The participant has Fitzpatrick skin type IV, V and VI, wide-spread acne, tattoos, or scarring interfering with the area of interest (that is, upper back).
- The participant is currently enrolled in another clinical trial or used any investigational drug or device within 3 months (or <5 half-lives of that product, whichever is longer) prior to dose of investigational medicinal product (IMP), or has participated in more than 4 investigational drug studies within 1 year prior to Screening.
- The participant takes any disallowed medication within 14 days from first dose of trial drug.
- The participant has been vaccinated ≤14 days prior to the first dose of IMP.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of child bearing potential and not willing to use adequate contraceptive methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Randomized, Double-blind, Placebo and Active Comparator-controlled, Four-way Crossover Trial Investigating the Analgesic Properties of a Single Oral Dose of Lu AG06474 in Healthy Participants
The main goal of this trial is to learn about the effect of Lu AG06474 on a battery of Evoked Pain Tests when a single dose is given to healthy adult participants. The effects of Lu AG06474 will be compared with 2 approved pain-relieving medications (ibuprofen and pregabalin) and with a placebo (a treatment that looks like the trial treatment but does not have any medicine in it). Each participant will receive 1 dose of each of these treatments during the trial (Lu AG06474, ibuprofen, pregabalin, and placebo), with 1 week between treatments. All treatments will be taken orally (by mouth), either as a liquid or a capsule.
- Conditions
- Healthy Participants
- Being tested
- Lu AG06474, Placebo to Lu AG06474, Ibuprofen, Pregabalin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG06474Drug
Oral solution
Placebo to Lu AG06474Drug
Oral solution
IbuprofenDrug
Capsule
PregabalinDrug
Capsule
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Part A: Lu AG06474 + Placebo | Experimental | Participants will receive a single dose of Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules). Receives: Drug: Lu AG06474; Drug: Placebo |
| Part B: Ibuprofen + Placebo to Lu AG06474 | Experimental | Participants will receive a single dose of ibuprofen (3 ibuprofen capsules) and a single dose of placebo to Lu AG06474 (oral solution). Receives: Drug: Placebo to Lu AG06474; Drug: Ibuprofen |
| Part C: Pregabalin + Placebo to Lu AG06474 | Experimental | Participants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution). Receives: Drug: Placebo to Lu AG06474; Drug: Pregabalin; Drug: Placebo |
| Part D: Placebo to Lu AG06474 + Placebo | Experimental | Participants will receive a single dose of placebo to Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules). Receives: Drug: Placebo to Lu AG06474; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain Test
The PDT is the degrees Celsius where the participant first detects pain.
Measured: Baseline to 6 hours post-dose
Change From Baseline in Pain Detection Thresholds (PDTs) for the Capsaicin Heat Pain Test
The PDT is the degrees Celsius where the participant first detects pain.
Measured: Baseline to 6 hours post-dose
Change From Baseline in Area of Secondary Mechanical Allodynia After the Capsaicin Challenge
The area of secondary mechanical allodynia will be reported for the capsaicin challenge, measured in squared millimeters (mm^2).
Measured: Baseline to 6 hours post-dose
Change From Baseline in Pain Tolerance Thresholds (PTTs) for the Cold Pressor Test
The PTT is the timepoint (in seconds) where the participant can no longer tolerate the pain.
Measured: Baseline to 6 hours post-dose
Change From Baseline in Pain Detection Thresholds (PDTs) for the Cold Pressor Test
The PDT is the timepoint (in seconds) where the participant first detects the pain.
Measured: Baseline to 6 hours post-dose
Secondary outcomes (4)
AUC0-8h: Area Under the Curve Concentration-time Curve from Zero to 8 hours Post-dose
Measured: 0 (predose) to 8 hours postdose on Day 1 to Day 22
Cmax: Maximum Observed Plasma Concentration
Measured: 0 (predose) to 8 hours postdose on Day 1 to Day 22
tmax: Nominal Time Corresponding to the Occurrence of Cmax
Measured: 0 (predose) to 8 hours postdose on Day 1 to Day 22
Difference to Placebo in Blood Levels of Endocannabinoids
Measured: 0 (predose) to 8 hours postdose on Day 1 to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start13 Oct 2023
- Primary completion10 May 2024
- Study completion17 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077786
- Sponsor's protocol ID
- 20435A
- Other IDs
- 2023-503987-18-00, 2023
- Status last verified
- Jun 2024
- First submitted
- 5 Oct 2023
- Last updated
- 28 Jun 2024
- 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 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Randomized, Double-blind, Placebo and Active Comparator-controlled, Four-way Crossover Trial Investigating the Analgesic Properties of a Single Oral Dose of Lu AG06474 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06077786
- Acronym / sponsor ID
- 20435A
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 11 Oct 2023 (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 trial is to learn about the effect of Lu AG06474 on a battery of Evoked Pain Tests when a single dose is given to healthy adult participants. The effects of Lu AG06474 will be compared with 2 approved pain-relieving medications (ibuprofen and pregabalin) and with a placebo (a treatment that looks like the trial treatment but does not have any medicine in it). Each participant will receive 1 dose of each of these treatments during the trial (Lu AG06474, ibuprofen, pregabalin, and placebo), with 1 week between treatments. All treatments will be taken orally (by mouth), either as a liquid or a capsule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: Lu AG06474 + Placebo | Experimental | Drug: Lu AG06474, Drug: PlaceboParticipants will receive a single dose of Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules). |
| Part B: Ibuprofen + Placebo to Lu AG06474 | Experimental | Drug: Placebo to Lu AG06474, Drug: IbuprofenParticipants will receive a single dose of ibuprofen (3 ibuprofen capsules) and a single dose of placebo to Lu AG06474 (oral solution). |
| Part C: Pregabalin + Placebo to Lu AG06474 | Experimental | Drug: Placebo to Lu AG06474, Drug: Pregabalin, Drug: PlaceboParticipants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution). |
| Part D: Placebo to Lu AG06474 + Placebo | Experimental | Drug: Placebo to Lu AG06474, Drug: PlaceboParticipants will receive a single dose of placebo to Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The participant has a body mass index (BMI) ≥18.5 and ≤32 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Trial 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 ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (6 listed)
- The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
- The participant has Fitzpatrick skin type IV, V and VI, wide-spread acne, tattoos, or scarring interfering with the area of interest (that is, upper back).
- The participant is currently enrolled in another clinical trial or used any investigational drug or device within 3 months (or <5 half-lives of that product, whichever is longer) prior to dose of investigational medicinal product (IMP), or has participated in more than 4 investigational drug studies within 1 year prior to Screening.
- The participant takes any disallowed medication within 14 days from first dose of trial drug.
- The participant has been vaccinated ≤14 days prior to the first dose of IMP.
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 AG06474Oral solution | Drug | Part A: Lu AG06474 + Placebo |
| Placebo to Lu AG06474Oral solution | Drug | Part B: Ibuprofen + Placebo to Lu AG06474, Part C: Pregabalin + Placebo to Lu AG06474, Part D: Placebo to Lu AG06474 + Placebo |
| IbuprofenCapsule | Drug | Part B: Ibuprofen + Placebo to Lu AG06474 |
| PregabalinCapsule | Drug | Part C: Pregabalin + Placebo to Lu AG06474 |
| PlaceboCapsule | Drug | Part A: Lu AG06474 + Placebo, Part C: Pregabalin + Placebo to Lu AG06474, Part D: Placebo to Lu AG06474 + Placebo |
Primary outcome
Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain Test
Time frame: Baseline to 6 hours post-dose
The PDT is the degrees Celsius where the participant first detects pain.
Change From Baseline in Pain Detection Thresholds (PDTs) for the Capsaicin Heat Pain Test
Time frame: Baseline to 6 hours post-dose
The PDT is the degrees Celsius where the participant first detects pain.
Change From Baseline in Area of Secondary Mechanical Allodynia After the Capsaicin Challenge
Time frame: Baseline to 6 hours post-dose
The area of secondary mechanical allodynia will be reported for the capsaicin challenge, measured in squared millimeters (mm^2).
Change From Baseline in Pain Tolerance Thresholds (PTTs) for the Cold Pressor Test
Time frame: Baseline to 6 hours post-dose
The PTT is the timepoint (in seconds) where the participant can no longer tolerate the pain.
Change From Baseline in Pain Detection Thresholds (PDTs) for the Cold Pressor Test
Time frame: Baseline to 6 hours post-dose
The PDT is the timepoint (in seconds) where the participant first detects the pain.
4 secondary outcomes
AUC0-8h: Area Under the Curve Concentration-time Curve from Zero to 8 hours Post-dose
Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
Cmax: Maximum Observed Plasma Concentration
Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
tmax: Nominal Time Corresponding to the Occurrence of Cmax
Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
Difference to Placebo in Blood Levels of Endocannabinoids
Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
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 28 Jun 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.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
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 AG06474, Ibuprofen and Pregabalin in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in Netherlands.
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 2 inclusion and 6 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 28 Jun 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 Netherlands. 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?
Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain Test (time frame: Baseline to 6 hours post-dose). The study lists 5 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 28 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.