A Relative Bioavailability Study of LY3209590 in Healthy Participants

NCT05615532
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Phase
Phase 1
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Recruitment status
Completed
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Participants
168
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Lead sponsor
Eli Lilly and Company
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Start date
2022-11-11
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Number of sites
1
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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.
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Short title
A Relative Bioavailability Study of LY3209590 in Healthy Participants
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-06-28
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First posted
2022-11-14
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Registry last updated
2024-06-12
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Primary completion date
2023-06-28
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Start date
2022-11-11
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Actual participants
168
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Participants
168
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05615532
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ClinicalTrials.gov ID
NCT05615532
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
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  1. Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590

    Timeframe: Predose on Day 1 through Day 65

    Part A: PK: AUC0-∞ of LY3209590

  1. Part B: PK: AUC0-∞ of LY3209590

    Timeframe: Predose on Day 1 through Day 65

    Part B: PK: AUC0-∞ of LY3209590

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
21 Years
Maximum age
65 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
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  • Lilly Centre for Clinical PharmacologySingapore, Singapore
Sources for sites
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Other registry identifiers

  • I8H-MC-BDDD
Sources for references
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Related records

Drugs (1)

Lead sponsors (1)