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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo to Lu AG06474; Drug: Lu AG06474; Drug: Pregabalin; Drug: Ibuprofen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06077786

20435A

2023-503987-18-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 4 patient groups

Part A: Lu AG06474 + Placebo

Experimental group

Description:

Participants will receive a single dose of Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules).

Treatment:

Drug: Placebo

Drug: Lu AG06474

Part B: Ibuprofen + Placebo to Lu AG06474

Experimental group

Description:

Participants will receive a single dose of ibuprofen (3 ibuprofen capsules) and a single dose of placebo to Lu AG06474 (oral solution).

Treatment:

Drug: Ibuprofen

Drug: Placebo to Lu AG06474

Part C: Pregabalin + Placebo to Lu AG06474

Experimental group

Description:

Participants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution).

Treatment:

Drug: Placebo

Drug: Pregabalin

Drug: Placebo to Lu AG06474

Part D: Placebo to Lu AG06474 + Placebo

Experimental group

Description:

Participants will receive a single dose of placebo to Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules).

Treatment:

Drug: Placebo

Drug: Placebo to Lu AG06474