A Safety Study of LY3372689 Given By Mouth to Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3372689; Drug: Placebo

• Registration Number: NCT03819270
• Lead Sponsor: 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 up to 3 doses of LY3372689 or placebo. The study will last about 12 weeks, including screening.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-02-05
• Primary Completion: 2019-06-23
• Study Completion: 2019-06-24
• Status Verified: 2019-07-01
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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• Have previously participated or withdrawn from this study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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3372689	LY3372689	Escalating doses of LY3372689 administered orally in healthy participants in two of three study periods
Placebo	Placebo	Matching placebo administered orally in healthy participants in one of three study periods

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689	Baseline through final follow-up at approximately Week 12	Pharmacokinetics: Tmax of LY3372689
Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689	Baseline through to final follow-up at approximately Week 12	Pharmacokinetics: Cmax of LY3372689
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689	Baseline through final follow-up at approximately Week 12	Pharmacokinetics: AUC of LY3372689

Trial Locations

Locations (1)

Covance; 🇺🇸 Dallas, Texas, United States