A Study of [14C]-LOXO-783 in Healthy Adult Participants

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 ([¹⁴C]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and [¹⁴C]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.

Official Title
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A Phase 1, Open-label Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LOXO-783 in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: [¹⁴C]-LOXO-783
* Drug: LOXO-783
* Drug: [¹⁴C]-LOXO-783


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, ECGs, vital signs, and clinical laboratory evaluations 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]-LOXO-783 (Part 1)<br>Single dose of [¹⁴C]-LOXO-783 administered orally | Drug: [¹⁴C]-LOXO-783<br>* Administered orally<br>* Other names: LY3849524;|
| Experimental: LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)<br>Single dose of LOXO-783 administered orally followed by single dose of [¹⁴C]-LOXO-783 administered intravenously (IV) | Drug: LOXO-783<br>* Administered orally<br>* Other names: LY3849524;Drug: [¹⁴C]-LOXO-783<br>* Administered IV<br>* Other names: LY3849524;|

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 LOXO-783 | PK: F of LOXO-783 | Predose on day 1 up to postdose on day 9 (Part 2) |