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A Safety Study of LY3372689 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04106206
Collaborator
(none)
54
Enrollment
1
Location
2
Arms
3.7
Actual Duration (Months)
14.7
Patients Per Site Per Month

Study Details

Study Description

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 multiple doses of LY3372689 or placebo and will remain in the study for up to eight weeks.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3372689
Actual Study Start Date :
Oct 23, 2019
Actual Primary Completion Date :
Feb 12, 2020
Actual Study Completion Date :
Feb 12, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3372689

LY3372689 administered orally

Drug: LY3372689
Administered orally
Placebo Comparator: Placebo

Placebo administered orally

Drug: Placebo
Administered orally

Outcome Measures

Primary Outcome Measures

  1. 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 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 Outcome Measures

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3372689 [Day 1 postdose through Day 15]

    PK: Cmax of LY3372689

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3372689 [Day 1 postdose through Day 15]

    PK: AUC of LY3372689

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Dallas Texas United States 75247-4989

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04106206
Other Study ID Numbers:
  • 17242
  • I9X-MC-MTAC
First Posted:
Sep 26, 2019
Last Update Posted:
Apr 24, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 24, 2020