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

• Status: Recruiting
• Trial end date: 2024-05-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Ibuprofen; Pregabalin

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.