A Relative Bioavailability Study of LY3454738 in Healthy Participants

NCT06173895 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18391J1B-MC-FRCJ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738

  PK: Cmax of LY3454738

  Predose on day 1 up to 85 days post dose

• 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

Study Arms (2)

LY3454738 (Test Formulation)

EXPERIMENTAL

Drug: LY3454738

LY3454738 (Reference Formulation)

EXPERIMENTAL

Drug: LY3454738

Interventions

LY3454738 DRUG

Administered subcutaneously (SC)

LY3454738 (Reference Formulation); LY3454738 (Test Formulation)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 12, 2024
• Primary Completion: May 2, 2024
• Study Completion: May 2, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)