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Completed

NCT Number: NCT05901311

A Study of [14C]-LY3537982 in Healthy Participants

The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days 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

Labcorp Clinical Research Unit Inc.

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 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

LY3537982

Drug

Administered orally.

Other names: Olomorasib

[¹⁴C]-LY3537982

Drug

Administered orally.

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 LY3537982

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

    PK: F of LY3537982

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

A Phase I, Open-label, Two-part Study of the Absorption, Metabolism, Excretion, and the Absolute Bioavailability of [14C]-LY3537982 in Healthy Adult Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Nov 8, 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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