Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT05477095
Eligibility Criteria:
Inclusion Criteria:
* Is a male or female aged 18 to 55 years old, inclusive, at time of informed consent.
* Has a body mass index between 18 and 30 kg/m2, inclusive at Screening, and with a minimum weight of 50 kg.
* Male participants and their partners of childbearing potential must commit to the use of highly effective contraceptives for the study duration and for at least 12 weeks after the last dose. Men must refrain from donating sperm during this same period.
* Female participants must be of nonchildbearing potential, or, for women of childbearing potential, must be willing to practice highly effective contraception throughout the duration of the study and for at least 24 weeks following the last dose.
* Other inclusion criteria apply
Exclusion Criteria:
* Has a history of clinically significant medical or psychiatric conditions, which in the opinion of the Investigator may compromise the participant's safety or the scientific value of the study, posing an unacceptable risk to the participant or interfere with the participant's ability to comply with study procedures or abide by study restrictions.
* Presents any concern by the Investigator regarding safe participation in the study or for any other reason (including contraindication to MRI) that the Investigator considers the participant inappropriate for participation in the study.
* Has a recent history (within the past year of Screening) of migraine headache.
* Has unsuitable skin characteristics for the dermal capsaicin challenge as determined by the Investigator.
* Has not demonstrated at least a 100% increase in dermal blood flow following capsaicin challenge as part of Screening procedures and measured through laser speckle contrast imaging.
* Other exclusion criteria apply
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05477095
Study Brief:
Protocol Section:
NCT05477095