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A Relative Bioavailability Study of LY3209590 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05615532
Collaborator
(none)
171
Enrollment
1
Location
5
Arms
6.8
Anticipated Duration (Months)
25.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.

The study may last up to 65 (part A) and 184 (part B) days, respectively.

Condition or Disease Intervention/Treatment Phase
  • Drug: LY3209590 (SC)
  • Drug: LY3209590 (IV)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
171 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part A is Parallel design and Part B is a crossover designPart A is Parallel design and Part B is a crossover design
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants
Actual Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
Jun 6, 2023
Anticipated Study Completion Date :
Jun 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3209590 (Part A - Upper Arm)

LY3209590 administered subcutaneously (SC) into the upper arm

Drug: LY3209590 (SC)
Administered SC.
Experimental: LY3209590 (Part A - Thigh)

LY3209590 administered SC into the thigh

Drug: LY3209590 (SC)
Administered SC.
Experimental: LY3209590 (Part A - Abdominal Wall)

LY3209590 administered SC into the abdominal wall

Drug: LY3209590 (SC)
Administered SC.
Experimental: LY3209590 (Part B - IV Dose)

LY3209590 administered intravenously (IV)

Drug: LY3209590 (IV)
Administered IV.
Experimental: LY3209590 (Part B - SC Dose)

LY3209590 administered SC into the abdominal wall

Drug: LY3209590 (SC)
Administered SC.

Outcome Measures

Primary Outcome Measures

  1. Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590 [Predose on Day 1 through Day 65]

    Part A: PK: AUC0-∞ of LY3209590

Secondary Outcome Measures

  1. Part B: PK: AUC0-∞ of LY3209590 [Predose on Day 1 through Day 65]

    Part B: PK: AUC0-∞ of LY3209590

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Male or female participants who are overtly healthy as determined by medical evaluation

  • Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)

  • Male or female participants must agree to use contraception

Exclusion Criteria:

  • Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction

  • Have known allergies to LY3209590, related compounds, or any components of the formulation

  • Have an abnormality in the 12-lead electrocardiogram

  • Intend to use prescription medication, including herbal medications and traditional medications

  • Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen

  • Are lactating or pregnant

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lilly Centre for Clinical Pharmacology Singapore Singapore 138623

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05615532
Other Study ID Numbers:
  • 18222
  • I8H-MC-BDDD
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 28, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Eli Lilly and Company
Bioavailability
Injection sites

Study Results

No Results Posted as of Nov 28, 2022