A Study to Compare Two Formulations of LY3209590 in Healthy Participants

Healthy Clinical Trial

Official title:

A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05914688
• Other study ID #: 18310
• Secondary ID: I8H-MC-BDDF
• Status: Completed
• Phase: Phase 1
• Start date: June 26, 2023
• Est. completion date: January 18, 2024

Study information

• Verified date: April 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 compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated. Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female participants who are overtly healthy as determined by medical evaluation
• Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive
• Contraceptive use by participants should be consistent with local regulations

Exclusion Criteria:

• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
• Have known allergies to LY3209590, related compounds, or any components of the formulation
• Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
• Have an abnormality in the 12-lead electrocardiogram (ECG)
• Are lactating or pregnant

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3209590 (Formulation 1)
Administered SC.
• LY3209590 (Formulation 2)
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 Time Point (AUC[0-tlast]) of LY3209590	PK: AUC(0-tlast) of LY3209590	Predose up to 65 days post dose
Primary	PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3209590	PK: AUC(0-8) of LY3209590	Predose up to 65 days post dose
Primary	PK: Maximum Observed Concentration (Cmax) of LY3209590	PK: Cmax of LY3209590	Predose up to 65 days post dose