Clinical trial NCT06077786: A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2023-10-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain Test
timeFrame: Baseline to 6 hours post-dose
measure: Change From Baseline in Pain Detection Thresholds (PDTs) for the Capsaicin Heat Pain Test
timeFrame: Baseline to 6 hours post-dose
measure: Change From Baseline in Area of Secondary Mechanical Allodynia After the Capsaicin Challenge
timeFrame: Baseline to 6 hours post-dose
measure: Change From Baseline in Pain Tolerance Thresholds (PTTs) for the Cold Pressor Test
timeFrame: Baseline to 6 hours post-dose
measure: Change From Baseline in Pain Detection Thresholds (PDTs) for the Cold Pressor Test
timeFrame: Baseline to 6 hours post-dose
Secondary outcomes:
measure: AUC0-8h: Area Under the Curve Concentration-time Curve from Zero to 8 hours Post-dose
timeFrame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
measure: Cmax: Maximum Observed Plasma Concentration
timeFrame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
measure: tmax: Nominal Time Corresponding to the Occurrence of Cmax
timeFrame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
measure: Difference to Placebo in Blood Levels of Endocannabinoids
timeFrame: 0 (predose) to 8 hours postdose on Day 1 to Day 22
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: