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Completed

NCT Number: NCT06077786

A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult 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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, 2333 CL, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AG06474

Drug

Oral solution

Placebo to Lu AG06474

Drug

Oral solution

Ibuprofen

Drug

Capsule

Pregabalin

Drug

Capsule

Placebo

Drug

Capsule

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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

  1. 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

  2. Cmax: Maximum Observed Plasma Concentration

    Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22

  3. tmax: Nominal Time Corresponding to the Occurrence of Cmax

    Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22

  4. Difference to Placebo in Blood Levels of Endocannabinoids

    Time frame: 0 (predose) to 8 hours postdose on Day 1 to Day 22

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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