Healthy Participants
Conditions
Brief 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 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.
Interventions
DRUGLu AG06474
Oral solution
DRUGPlacebo to Lu AG06474
Oral solution
DRUGIbuprofen
Capsule
DRUGPregabalin
Capsule
DRUGPlacebo
Capsule
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Detection Thresholds (PDTs) for the Cold Pressor Test | Baseline to 6 hours post-dose | The PDT is the timepoint (in seconds) where the participant first detects the pain. |
| Change From Baseline in Area of Secondary Mechanical Allodynia After the Capsaicin Challenge | 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 Detection Thresholds (PDTs) for the UVB Heat Pain Test | 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 | Baseline to 6 hours post-dose | The PDT is the degrees Celsius where the participant first detects pain. |
| Change From Baseline in Pain Tolerance Thresholds (PTTs) for the Cold Pressor Test | Baseline to 6 hours post-dose | The PTT is the timepoint (in seconds) where the participant can no longer tolerate the pain. |
Secondary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
| tmax: Nominal Time Corresponding to the Occurrence of Cmax | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
| Difference to Placebo in Blood Levels of Endocannabinoids | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
| AUC0-8h: Area Under the Curve Concentration-time Curve from Zero to 8 hours Post-dose | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
Countries
Netherlands
Outcome results
None listed