A Safety Study of LY3372689 Given By Mouth to Healthy Participants

July 2, 2019 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • Have previously participated or withdrawn from this study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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
Baseline through final follow-up at approximately Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2019

Primary Completion (Actual)

June 23, 2019

Study Completion (Actual)

June 24, 2019

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 17219
  • I9X-MC-MTAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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