A Study to Compare Two Formulations of LY3819469 in Healthy Participants

January 4, 2024 updated by: Eli Lilly and Company

A Single Dose Study to Assess the Pharmacokinetics of 2 Formulations of LY3819469 in Healthy Participants

The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

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

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male and female participants who are overtly healthy as determined by medical evaluation
  • Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening
  • Are male or women not of childbearing potential

Exclusion Criteria:

  • Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data
  • Have any abnormality in the 12-lead electrocardiogram (ECG)
  • Are heavy alcohol drinkers or heavy cigarette smokers
  • Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission
  • Have lost or donated blood of more than 450 mililitres (mL) within 3 months

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3819469 (Reference)
LY3819469 administered subcutaneously (SC).
Drug: LY3819469
Administered SC.
Experimental: LY3819469 (Test)
LY3819469 administered SC.
Drug: LY3819469
Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469
Time Frame: Predose on day 1 up to postdose on day 85
PK: AUC[0-tlast] of LY3819469
Predose on day 1 up to postdose on day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469
Time Frame: Predose on day 1 up to postdose on day 85
PK: AUC[0-∞] of LY3819469
Predose on day 1 up to postdose on day 85
PK: Maximum Observed Concentration (Cmax) of LY3819469
Time Frame: Predose on day 1 up to postdose on day 85
PK: Cmax of LY3819469
Predose on day 1 up to postdose on day 85

Collaborators and Investigators

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

Sponsor

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 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)

June 30, 2023

Primary Completion (Actual)

November 7, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 18730
  • J3L-MC-EZEE (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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