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

June 26, 2024 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2333 CL
        • Centre For Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Placebo
Capsule
Drug: Lu AG06474
Oral solution
Experimental: 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).
Drug: Placebo to Lu AG06474
Oral solution
Drug: Ibuprofen
Capsule
Experimental: 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).
Drug: Placebo
Capsule
Drug: Placebo to Lu AG06474
Oral solution
Drug: Pregabalin
Capsule
Experimental: 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).
Drug: Placebo
Capsule
Drug: Placebo to Lu AG06474
Oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 hours post-dose
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.
Baseline to 6 hours post-dose
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).
Baseline to 6 hours post-dose
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.
Baseline to 6 hours post-dose
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.
Baseline to 6 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
0 (predose) to 8 hours postdose on Day 1 to Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2023

Primary Completion (Actual)

May 10, 2024

Study Completion (Actual)

May 17, 2024

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20435A
  • 2023-503987-18-00 (Other Identifier: CTIS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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