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A Study to Compare Two Formulations of LY3819469 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05932446
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
4.5
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single Dose Study to Assess the Pharmacokinetics of 2 Formulations of LY3819469 in Healthy Participants
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Nov 13, 2023
Anticipated Study Completion Date :
Nov 13, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3819469 (Reference)

LY3819469 administered subcutaneously (SC).

Drug: LY3819469
Administered SC.
Experimental: LY3819469 (Test)

LY3819469 administered SC.

Drug: LY3819469
Administered SC.

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469 [Predose on day 1 up to postdose on day 85]

    PK: AUC[0-tlast] of LY3819469

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469 [Predose on day 1 up to postdose on day 85]

    PK: AUC[0-∞] of LY3819469

  3. PK: Maximum Observed Concentration (Cmax) of LY3819469 [Predose on day 1 up to postdose on day 85]

    PK: Cmax of LY3819469

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lilly Centre for Clinical Pharmacology Singapore Singapore 138623

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:
NCT05932446
Other Study ID Numbers:
  • 18730
  • J3L-MC-EZEE
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jun 15, 2023
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 Jul 6, 2023