A Safety Study of LY3372689 Given By Mouth to Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03819270
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 5

Study Details

Study Description

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 up to 3 doses of LY3372689 or placebo. The study will last about 12 weeks, including screening.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3372689; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689
• Actual Study Start Date: Feb 5, 2019
• Actual Primary Completion Date: Jun 23, 2019
• Actual Study Completion Date: Jun 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3372689 Escalating doses of LY3372689 administered orally in healthy participants in two of three study periods	Drug: LY3372689; Administered orally
Placebo Comparator: Placebo Matching placebo administered orally in healthy participants in one of three study periods	Drug: Placebo; Administered orally

Outcome Measures

Primary Outcome Measures

1. 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 Week 12]

   A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

1. Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689 [Baseline through to final follow-up at approximately Week 12]

   Pharmacokinetics: Cmax of LY3372689

2. Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689 [Baseline through final follow-up at approximately Week 12]

   Pharmacokinetics: Tmax of LY3372689

3. Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689 [Baseline through final follow-up at approximately Week 12]

   Pharmacokinetics: AUC of LY3372689

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Overtly healthy male or a female who cannot get pregnant

• Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening

• 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

• Have long exposure to sunlight routinely or use tanning beds regularly

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance	Dallas	Texas	United States	75247

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03819270
• Other Study ID Numbers: 17219; I9X-MC-MTAA
• First Posted: Jan 28, 2019
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 5, 2019