A Relative Bioavailability Study of LY3454738 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-Label Study to Determine the Relative Bioavailability of LY3454738 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173895
• Other study ID #: 18391
• Secondary ID: J1B-MC-FRCJ
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2024
• Est. completion date: May 2, 2024

Study information

• Verified date: May 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 look at the amount of the study drug, LY3454738 that gets into the blood stream and how long it takes the body to get rid of it when given under the skin comparing a test formulation versus a reference formulation in healthy participants. The study will also evaluate the safety and tolerability of LY3454738 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical history and physical examination.

• Have body mass index (BMI) between 18.0 and 28.0 kilograms per meter squared (kg/m²), inclusive, at screening.

Exclusion Criteria:

• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data.

• Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study.

• Show evidence of active or latent TB.

• Have one of the following infections: hepatitis B virus or human immunodeficiency virus (HIV).

• Participants must not be currently participating in or completed a clinical trial within the last 30 days

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3454738
Administered subcutaneously (SC)

Locations

Country	Name	City	State
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738	PK: Cmax of LY3454738	Predose on day 1 up to 85 days post dose
Primary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738	PK: AUC of LY3454738	Predose on day 1 up to 85 days post dose