A Study to Compare Two Formulations of LY3819469 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05932446
• Other study ID #: 18730
• Secondary ID: J3L-MC-EZEE
• Status: Completed
• Phase: Phase 1
• Start date: June 30, 2023
• Est. completion date: November 7, 2023

Study information

• Verified date: January 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3819469
Administered SC.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469	PK: AUC[0-tlast] of LY3819469	Predose on day 1 up to postdose on day 85
Primary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) of LY3819469	PK: AUC[0-8] of LY3819469	Predose on day 1 up to postdose on day 85
Primary	PK: Maximum Observed Concentration (Cmax) of LY3819469	PK: Cmax of LY3819469	Predose on day 1 up to postdose on day 85