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A Safety Study of LY3372689 Given By Mouth to Healthy Participants

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03819270
Enrollment
23
Registered
2019-01-28
Start date
2019-02-05
Completion date
2019-06-24
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

Administered orally

DRUGPlacebo

Administered orally

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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days or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure * Have or used to have health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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Observed by the Investigator During Study Drug AdministrationBaseline through final follow-up at approximately Week 12A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary

MeasureTime frameDescription
Pharmacokinetics: Maximum Concentration (Cmax) of LY3372689Baseline through to final follow-up at approximately Week 12Pharmacokinetics: Cmax of LY3372689
Pharmacokinetics: Time to Maximum Blood Concentration (Tmax) of LY3372689Baseline through final follow-up at approximately Week 12Pharmacokinetics: Tmax of LY3372689
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3372689Baseline through final follow-up at approximately Week 12Pharmacokinetics: AUC of LY3372689

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026