A Relative Bioavailability Study of LY3454738 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3454738

• Registration Number: NCT06173895
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Study Start: 2024-01-12
• Status Verified: 2024-05
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3454738 (Test Formulation)	LY3454738	-
LY3454738 (Reference Formulation)	LY3454738	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738	Predose on day 1 up to 85 days post dose	PK: Cmax of LY3454738
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738	Predose on day 1 up to 85 days post dose	PK: AUC of LY3454738

Trial Locations

Locations (1)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States