A Study of LY3526318 in Healthy Women

• ClinicalTrials.gov Identifier: NCT04183283
• Recruitment Status: Completed
• First Posted: December 3, 2019
• Last Update Posted: March 17, 2020
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: LY3526318; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: December 12, 2019
• Actual Primary Completion Date: February 28, 2020
• Actual Study Completion Date: March 6, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium, 3000

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• Study Director: 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

More Information

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04183283
• Other Study ID Numbers: 17482; J2D-MC-CVAB ( Other Identifier: Eli Lilly and Company ); 2019-003613-34 ( EudraCT Number )
• First Posted: December 3, 2019
• Last Update Posted: March 17, 2020
• Last Verified: March 15, 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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