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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pain Detection Thresholds (PDTs) for the Capsaicin Heat Pain Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Part D: Placebo to Lu AG06474 + Placebo
Participants will receive a single dose of placebo to Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules).
Intervention: Placebo (Drug)
Part A: Lu AG06474 + Placebo
Participants will receive a single dose of Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules).
Intervention: Lu AG06474 (Drug)
Part A: Lu AG06474 + Placebo
Participants will receive a single dose of Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules).
Intervention: Placebo (Drug)
Part B: Ibuprofen + Placebo to Lu AG06474
Participants will receive a single dose of ibuprofen (3 ibuprofen capsules) and a single dose of placebo to Lu AG06474 (oral solution).
Intervention: Placebo to Lu AG06474 (Drug)
Part B: Ibuprofen + Placebo to Lu AG06474
Participants will receive a single dose of ibuprofen (3 ibuprofen capsules) and a single dose of placebo to Lu AG06474 (oral solution).
Intervention: Ibuprofen (Drug)
Part C: Pregabalin + Placebo to Lu AG06474
Participants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution).
Intervention: Placebo to Lu AG06474 (Drug)
Part C: Pregabalin + Placebo to Lu AG06474
Participants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution).
Intervention: Pregabalin (Drug)
Part C: Pregabalin + Placebo to Lu AG06474
Participants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution).
Intervention: Placebo (Drug)
Part D: Placebo to Lu AG06474 + Placebo
Participants will receive a single dose of placebo to Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules).
Intervention: Placebo to Lu AG06474 (Drug)
Outcomes
Primary Outcomes
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 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 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.
Secondary Outcomes
- 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)
- Difference to Placebo in Blood Levels of Endocannabinoids(0 (predose) to 8 hours postdose on Day 1 to Day 22)
- 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)