A Safety Study of LY3372689 in Healthy Participants

Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689

Sponsors

Lead Sponsor: Eli Lilly and Company

Source Eli Lilly and Company
Brief Summary

This study is being conducted to determine the safety profile of the study drug after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3372689 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3372689 or placebo and will remain in the study for up to eight weeks.

Overall Status Completed
Start Date October 23, 2019
Completion Date February 12, 2020
Primary Completion Date February 12, 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration Baseline through final follow-up at approximately Day 30
Secondary Outcome
Measure Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372689 Day 1 postdose through Day 15
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372689 Day 1 postdose through Day 15
Enrollment 54
Condition
Intervention

Intervention Type: Drug

Intervention Name: LY3372689

Description: Administered orally

Arm Group Label: LY3372689

Intervention Type: Drug

Intervention Name: Placebo

Description: Administered orally

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

- Overtly healthy vasectomized male or a female who cannot get pregnant

- Have a body mass index (BMI) of 18.5 to ≤30 kilograms per square meter (kg/m²)

- Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study

- Have veins suitable for ease of blood sampling

Exclusion Criteria:

- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

- Have previously participated or withdrawn from this study

- Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure

- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Location
Facility: Covance
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: LY3372689

Type: Experimental

Description: LY3372689 administered orally

Label: Placebo

Type: Placebo Comparator

Description: Placebo administered orally

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov