Early study probes how new drug affects skin blood flow
NCT ID NCT04183283
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tested a single oral dose of LY3526318 in 16 healthy women to see how it affects blood flow in the skin after exposure to cinnamaldehyde (a compound in cinnamon). The goal was to understand the drug's basic effects, not to treat any disease. The study is complete.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LY3526318
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
16 people
The number who actually took part.
- Started
-
Dec 2019
- Finished
-
Mar 2020
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Must be healthy female participants as determined by medical history and physical examination --Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized \[for example (e.g.) tubal occlusion, hysterectomy, bilateral salpingectomy\] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months) * Must have a body-mass index of 18 to 30 kilograms per square meter, inclusive * Must be willing to follow specific study procedures including * No drugs (except study drug, hormonal contraceptives) 7 days prior to each assessment and until discharge from Clinical Research Unit (CRU) * No chocolate, alcohol, or caffeine containing products 24 hours prior to initiation of each assessment and until discharge * A complete 4 hour fast (water is allowed) prior to cinnamaldehyde (CA) assessment * Must have suitable skin characteristics for the dermal CA challenge procedures and measured through Laser Doppler Imaging (LDI) Exclusion Criteria: * Must not be currently enrolled in or discontinued within the last 30 days or 5 half-lives of the study drug (whichever is longer), from a clinical study involving an investigational product or any type of medical research judged not compatible with this study * Must not have received treatment with biological agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing * Must not have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality that would preclude study participation * Must not have an abnormality in the 12-lead electrocardiogram (ECG) or confirmed Frederica's corrected QT interval greater than (\>) 470 millisecond (msec) * Must not have a history of clinically significant multiple or severe drug allergies or severe post-treatment hypersensitivity reactions * Must avoid excessive tanning * Must not use lotions, oils, depilatory preparations, makeup, or other topical treatments on the arms on a regular basis or have used any topical treatments within 7 days prior to start of the first study day * Must not be a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee, or cola drinks/day) or who cannot refrain from caffeinated beverages 24 hours prior to CA application * Must not be drinking alcohol 24 hours prior to each assessment * Must not be around second-hand smoke 24 hours prior to CA application or use nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
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