A Study of [14C]-LY3537982 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days and 61 days for part 1 and 2, respectively.

Official Title
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A Phase I, Open-label, Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LY3537982 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3537982
* Drug: [¹⁴C]-LY3537982
* Drug: [¹⁴C]-LY3537982


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination as assessed by the investigator. Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²) Female participants of non-childbearing potential and male participants who follow standard contraceptive methods. Exclusion Criteria: History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor Known ongoing alcohol and/or drug abuse within 2 years prior to Screening History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [¹⁴C]-LY3537982 (Part 1)<br>Single dose of [¹⁴C]-LY3537982 administered orally. | Drug: [¹⁴C]-LY3537982<br>* Administered orally.<br>|
| Experimental: [¹⁴C]-LY3537982 + LY3537982 (Part 2)<br>Single dose of LY3537982 administered orally followed by [¹⁴C]-LY3537982 administered intravenously (IV). | Drug: LY3537982<br>* Administered orally.<br>Drug: [¹⁴C]-LY3537982<br>* Administered IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) | PK: Feur | Predose on day 1 up to postdose on day 21 (Part 1) | 
| PK: Cumulative Feur | PK: Cumulative Feur | Predose on day 1 up to postdose on day 21 (Part 1) | 
| PK: Fraction of Dose Excreted in Feces (Fefeces) | PK: Fefeces | Predose on day 1 up to postdose on day 21 (Part 1) | 
| PK: Cumulative Fefeces | PK: Cumulative Fefeces | Predose on day 1 up to postdose on day 21 (Part 1) | 
| PK: Fraction of Dose Excreted in Expired Air (Feair) | PK: Feair | Predose on day 1 up to postdose on day 21 (Part 1) | 
| PK: Absolute Bioavailability (F) of LY3537982 | PK: F of LY3537982 | Predose on day 1 up to postdose on day 9 (Part 2) |