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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: [¹⁴C]-LOXO-783; Drug: [¹⁴C]-LOXO-783; Drug: LOXO-783

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Patient Advocacy; Phone Number: 8555696305; Email: clinicaltrials@loxooncology.com

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortrea Clinical Research
      • Contact: Phone Number: 608-210-5454
      • Principal Investigator: Nicolas Siebers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [¹⁴C]-LOXO-783 (Part 1); Single dose of [¹⁴C]-LOXO-783 administered orally	Drug: [¹⁴C]-LOXO-783; Administered orally; Other Names: LY3849524; Drug: [¹⁴C]-LOXO-783; Administered IV; Other Names: LY3849524
Experimental: 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)	Drug: [¹⁴C]-LOXO-783; Administered orally; Other Names: LY3849524; Drug: [¹⁴C]-LOXO-783; Administered IV; Other Names: LY3849524; Drug: LOXO-783; Administered orally; Other Names: LY3849524

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: Yingying Guo-Avrutin, Loxo Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 23, 2023
• Primary Completion (Estimated): January 11, 2024
• Study Completion (Estimated): January 11, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LOXO-PIK-23005; J4C-OX-JZUE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No