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OpenTrials
Completed

NCT Number: NCT06173895

A Relative Bioavailability Study of LY3454738 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3454738

Drug

Administered subcutaneously (SC)

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738

    Time frame: Predose on day 1 up to 85 days post dose

    PK: Cmax of LY3454738

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738

    Time frame: Predose on day 1 up to 85 days post dose

    PK: AUC of LY3454738

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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