Status:
COMPLETED
A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06077786
Start Date
October 13 2023
End Date
May 17 2024
Last Update
June 28 2024
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333 CL