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Completed

NCT Number: NCT06102512

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[¹⁴C]-LOXO-783

Drug

Administered orally

Other names: LY3849524

LOXO-783

Drug

Administered orally

Other names: LY3849524

Primary outcomes

  1. Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)

    Time frame: Predose on day 1 up to postdose on day 21 (Part 1)

    PK: Feur

  2. PK: Cumulative Feur

    Time frame: Predose on day 1 up to postdose on day 21 (Part 1)

    PK: Cumulative Feur

  3. PK: Fraction of Dose Excreted in Feces (Fefeces)

    Time frame: Predose on day 1 up to postdose on day 21 (Part 1)

    PK: Fefeces

  4. PK: Cumulative Fefeces

    Time frame: Predose on day 1 up to postdose on day 21 (Part 1)

    PK: Cumulative Fefeces

  5. PK: Fraction of Dose Excreted in Expired Air (Feair)

    Time frame: Predose on day 1 up to postdose on day 21 (Part 1)

    PK: Feair

  6. PK: Absolute Bioavailability (F) of LOXO-783

    Time frame: Predose on day 1 up to postdose on day 9 (Part 2)

    PK: F of LOXO-783

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 26, 2023
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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