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OpenTrials
Completed

NCT Number: NCT04106206

A Safety Study of LY3372689 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Dallas, Texas, 75247-4989, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously participated or withdrawn from this study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

Treatment and study plan

LY3372689

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

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

    Time frame: Baseline through final follow-up at approximately Day 30

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

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372689

    Time frame: Day 1 postdose through Day 15

    PK: Cmax of LY3372689

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372689

    Time frame: Day 1 postdose through Day 15

    PK: AUC of LY3372689

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2019
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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