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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: [¹⁴C]-LOXO-783; Drug: LOXO-783

Study type: Interventional

Funder types: Industry

Identifiers

NCT06102512

J4C-OX-JZUE (Other Identifier)

LOXO-PIK-23005

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

[¹⁴C]-LOXO-783 (Part 1)

Experimental group

Description:

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

Treatment:

Drug: [¹⁴C]-LOXO-783

Drug: [¹⁴C]-LOXO-783

LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

Experimental group

Description:

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

Treatment:

Drug: [¹⁴C]-LOXO-783

Drug: LOXO-783

Drug: [¹⁴C]-LOXO-783