A Study of LY3526318 in Healthy Women

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3526318

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3526318; LY3526318 administered orally in three of four study periods.	Drug: LY3526318; Administered orally.
Placebo Comparator: Placebo; Placebo administered orally in one of four study periods.	Drug: Placebo; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Cinnamaldehyde (CA)-Induced Dermal Blood Flow (DBF) Measured by Laser Doppler Imaging (LDI)	CA-induced DBF measured by laser doppler imaging (LDI)	Baseline, 3 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in CA-induced DBF Measured by Laser Speckle Contrast Imaging (LSCI)	CA-induced DBF measured by LSCI	Baseline, 3 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318	PK: AUC of LY3526318	Predose on Day 1 through Day 50
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318	PK: Cmax of LY3526318	Predose on Day 1 through Day 50

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 15, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17482 (Other Identifier: City of Hope Comprehensive Cancer Center); J2D-MC-CVAB (Other Identifier: Eli Lilly and Company); 2019-003613-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No