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

NCT06102512 | Completed Phase 1 FDA Drug

• 2 other identifiers: LOXO-PIK-23005J4C-OX-JZUE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

[¹⁴C]-LOXO-783 (Part 1)

EXPERIMENTAL

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

Drug: [¹⁴C]-LOXO-783

LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

EXPERIMENTAL

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

Drug: LOXO-783; Drug: [¹⁴C]-LOXO-783

Interventions

[¹⁴C]-LOXO-783 DRUG

Administered orally

Also known as: LY3849524

[¹⁴C]-LOXO-783 (Part 1)

LOXO-783 DRUG

Administered orally

Also known as: LY3849524

LOXO-783 + [¹⁴C]-LOXO-783 (Part 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Loxo Oncology, Inc.: collaborator

Study Sites (1)

Fortrea Clinical Research

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Yingying Guo-Avrutin

  Loxo Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: October 23, 2023
• Primary Completion: December 23, 2023
• Study Completion: January 17, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)