A Study of [¹⁴C]-LY3484356 in Healthy Female Participants

Study Overview
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Brief Summary
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The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

Official Title
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An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential

Conditions
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Healthy

Intervention / Treatment
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* Drug: [¹⁴C]-LY3484356
* Drug: LY3484356
* Drug: [¹⁴C]-LY3484356 (IV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal. Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²) Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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]-LY3484356 (Part 1)<br>Single dose of [¹⁴C]-LY3484356 administered orally. | Drug: [¹⁴C]-LY3484356<br>* Administered orally.<br>|
| Experimental: LY3484356 + [¹⁴C]-LY3484356 (Part 2)<br>Single dose of LY3484356 administered orally followed by Single dose of [¹⁴C]-LY3484356 administered intravenously (IV). | Drug: LY3484356<br>* Administered orally.<br>Drug: [¹⁴C]-LY3484356 (IV)<br>* Administered IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 12 post dose | 
| Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3484356 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 12 post dose | 
| Pharmacokinetics (PK): Absolute Bioavailability of LY3484356 | PK: Absolute Bioavailability of LY3484356 | Predose up to Day 9 post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 | PK: (AUC (0-∞)) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 | Predose up to Day 12 post dose | 
| PK: Maximum Concentration (Cmax) of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 | PK: Cmax of Total Radioactivity, LY3484356 and [¹⁴C]-LY3484356 | Predose up to Day 12 post dose | 
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable). | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable). | Predose up to Day 12 post dose | 
| Total Number of Metabolites of LY3484356 | Total Number of Metabolites of LY3484356 | Predose up to Day 12 post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism, Absolute Bioavailability, Disposition