A Safety Study of LY3372689 Given By Mouth to Healthy Participants

NCT03819270 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17219I9X-MC-MTAA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug Administration

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

  Baseline through final follow-up at approximately Week 12

Secondary Outcomes (3)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689

  Baseline through to final follow-up at approximately Week 12

• Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689

  Baseline through final follow-up at approximately Week 12

• Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689

  Baseline through final follow-up at approximately Week 12

Study Arms (2)

LY3372689

EXPERIMENTAL

Escalating doses of LY3372689 administered orally in healthy participants in two of three study periods

Drug: LY3372689

Placebo

PLACEBO COMPARATOR

Matching placebo administered orally in healthy participants in one of three study periods

Drug: Placebo

Interventions

LY3372689 DRUG

Administered orally

LY3372689

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

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

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: January 25, 2019
• First Posted: January 28, 2019
• Study Start: February 5, 2019
• Primary Completion: June 23, 2019
• Study Completion: June 24, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)