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A Relative Bioavailability Study of LY3454738 in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3454738

Study type

Interventional

Funder types

Industry

Identifiers

NCT06173895
J1B-MC-FRCJ (Other Identifier)
18391

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

LY3454738 (Test Formulation)
Experimental group
Treatment:
Drug: LY3454738
LY3454738 (Reference Formulation)
Experimental group
Treatment:
Drug: LY3454738

Trial contacts and locations

1

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Central trial contact

This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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