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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2024-01-17

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[¹⁴C]-LOXO-783 (Part 1)

Single dose of \[¹⁴C\]-LOXO-783 administered orally

Group Type EXPERIMENTAL

[¹⁴C]-LOXO-783

Intervention Type DRUG

Administered orally

LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

Single dose of LOXO-783 administered orally followed by single dose of \[¹⁴C\]-LOXO-783 administered intravenously (IV)

Group Type EXPERIMENTAL

LOXO-783

Intervention Type DRUG

Administered orally

[¹⁴C]-LOXO-783

Intervention Type DRUG

Administered IV

Interventions

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[¹⁴C]-LOXO-783

Administered orally

Intervention Type DRUG

LOXO-783

Administered orally

Intervention Type DRUG

[¹⁴C]-LOXO-783

Administered IV

Intervention Type DRUG

Other Intervention Names

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LY3849524 LY3849524 LY3849524

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes