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

NCT ID: NCT06077786

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2024-05-17

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Lu AG06474

Intervention Type: DRUG

Oral solution

Placebo

Intervention Type: DRUG

Capsule

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).

Group Type: EXPERIMENTAL

Placebo to Lu AG06474

Intervention Type: DRUG

Oral solution

Ibuprofen

Intervention Type: DRUG

Capsule

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).

Group Type: EXPERIMENTAL

Placebo to Lu AG06474

Intervention Type: DRUG

Oral solution

Pregabalin

Intervention Type: DRUG

Capsule

Placebo

Intervention Type: DRUG

Capsule

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).

Group Type: EXPERIMENTAL

Placebo to Lu AG06474

Intervention Type: DRUG

Oral solution

Placebo

Intervention Type: DRUG

Capsule

Interventions

Lu AG06474

Oral solution

Intervention Type: DRUG

Placebo to Lu AG06474

Oral solution

Intervention Type: DRUG

Ibuprofen

Capsule

Intervention Type: DRUG

Pregabalin

Capsule

Intervention Type: DRUG

Placebo

Capsule

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

Centre for Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

2023-503987-18-00

Identifier Type: OTHER

Identifier Source: secondary_id

20435A

Identifier Type: -

Identifier Source: org_study_id