A Study of LY3526318 in Healthy Women

NCT04183283 | Completed Phase 1 Results

• 3 other identifiers: 17482J2D-MC-CVAB2019-003613-34
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Decrease in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Doppler Imaging (LDI) at 3 Hours Post-dose (LDI)

  CA-induced DBF was measured by laser doppler imaging (LDI). Least Squares (LS) mean was determined by analysis of variance (ANOVA) model with treatment, period, sequence, time and treatment\*time interaction as fixed factors and subject within sequence as a random factor.

  3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)

Secondary Outcomes (4)

• Decrease in CA-induced Dermal Blood Flow (DBF) Relative to Placebo Measured by Laser Speckle Contrast Imaging (LSCI) at 3 Hours Post-dose (LSCI)

  3 hours post LY3526318 dose (pre-CA challenge), 3.3 hours post LY3526318 dose (post-CA challenge)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318

  Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)

• PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

  Predose, 3 hours and 24 hours after each LY3526318 dose (days 1 through 50)

• Plasma Concentrations of LY3526318 at 3 and 24 Hours

  3 hours and 24 hours post dose

Study Arms (2)

LY3526318

EXPERIMENTAL

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

Drug: LY3526318

Placebo

PLACEBO COMPARATOR

Placebo administered orally in one of four study periods.

Drug: Placebo

Interventions

LY3526318 DRUG

Administered orally.

LY3526318

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 3, 2019
• Study Start: December 12, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 6, 2020
• Last Updated: October 6, 2025
• Results First Posted: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)