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

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077786
• Other study ID #: 20435A
• Secondary ID: 2023-503987-18-0
• Status: Recruiting
• Phase: Phase 1
• Start date: October 13, 2023
• Est. completion date: May 17, 2024

Study information

• Verified date: May 2024
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 17, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lu AG06474
Oral solution
• Placebo to Lu AG06474
Oral solution
• Ibuprofen
Capsule
• Pregabalin
Capsule
• Placebo
Capsule

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain Test	The PDT is the degrees Celsius where the participant first detects pain.	Baseline to 6 hours post-dose
Primary	Change From Baseline in Pain Detection Thresholds (PDTs) for the Capsaicin Heat Pain Test	The PDT is the degrees Celsius where the participant first detects pain.	Baseline to 6 hours post-dose
Primary	Change From Baseline in Area of Secondary Mechanical Allodynia After the Capsaicin Challenge	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
Primary	Change From Baseline in Pain Tolerance Thresholds (PTTs) for the Cold Pressor Test	The PTT is the timepoint (in seconds) where the participant can no longer tolerate the pain.	Baseline to 6 hours post-dose
Primary	Change From Baseline in Pain Detection Thresholds (PDTs) for the Cold Pressor Test	The PDT is the timepoint (in seconds) where the participant first detects the pain.	Baseline to 6 hours post-dose
Secondary	AUC0-8h: Area Under the Curve Concentration-time Curve from Zero to 8 hours Post-dose		0 (predose) to 8 hours postdose on Day 1 to Day 22
Secondary	Cmax: Maximum Observed Plasma Concentration		0 (predose) to 8 hours postdose on Day 1 to Day 22
Secondary	tmax: Nominal Time Corresponding to the Occurrence of Cmax		0 (predose) to 8 hours postdose on Day 1 to Day 22
Secondary	Difference to Placebo in Blood Levels of Endocannabinoids		0 (predose) to 8 hours postdose on Day 1 to Day 22