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A Safety Study of LY3372689 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106206
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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 multiple doses of LY3372689 or placebo and will remain in the study for up to eight weeks.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3372689 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : October 23, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : February 12, 2020

Arm Intervention/treatment
Experimental: LY3372689
LY3372689 administered orally
Drug: LY3372689
Administered orally

Placebo Comparator: Placebo
Placebo administered orally
Drug: Placebo
Administered orally




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106206


Locations
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United States, Texas
Covance
Dallas, Texas, United States, 75247-4989
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04106206    
Other Study ID Numbers: 17242
I9X-MC-MTAC ( Other Identifier: Eli Lilly and Company )
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No