Clinical trial NCT04183283: A Study of LY3526318 in Healthy Women
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Oral Single-Doses of LY3526318 on Cinnamaldehyde-Induced Dermal Blood Flow in Healthy Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about how LY3526318 affects blood flow to the skin in healthy women. For each participant, the study will last up to 28 days and Part B will last up to 78 days, including screening and follow-up.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Measured by Laser Doppler Imaging (LDI)
timeFrame: Baseline, 3 hours post-dose
Secondary outcomes:
measure: Change from Baseline in CA-induced DBF Measured by Laser Speckle Contrast Imaging (LSCI)
timeFrame: Baseline, 3 hours post-dose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
timeFrame: Predose on Day 1 through Day 50
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
timeFrame: Predose on Day 1 through Day 50
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: