A Study of LY3526318 in Healthy Women

NCT ID: NCT04183283

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-12
• Study Completion Date: 2020-03-06

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3526318

10 milligrams (mg), 30 mg and 100 mg LY3526318 administered orally in three of four study periods.

Group Type: EXPERIMENTAL

LY3526318

Intervention Type: DRUG

Administered orally.

Placebo

Placebo administered orally in one of four study periods.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally.

Interventions

LY3526318

Administered orally.

Intervention Type: DRUG

Placebo

Administered orally.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

J2D-MC-CVAB

Identifier Type: OTHER

Identifier Source: secondary_id

2019-003613-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17482

Identifier Type: -

Identifier Source: org_study_id