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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3537982; Drug: [¹⁴C]-LY3537982; Drug: [¹⁴C]-LY3537982

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

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research Unit Inc.

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 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]-LY3537982 (Part 1); Single dose of [¹⁴C]-LY3537982 administered orally.	Drug: [¹⁴C]-LY3537982; Administered orally.; Drug: [¹⁴C]-LY3537982; Administered IV.
Experimental: [¹⁴C]-LY3537982 + LY3537982 (Part 2); Single dose of LY3537982 administered orally followed by [¹⁴C]-LY3537982 administered intravenously (IV).	Drug: LY3537982; Administered orally.; Other Names: Olomorasib; Drug: [¹⁴C]-LY3537982; Administered orally.; Drug: [¹⁴C]-LY3537982; Administered IV.

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 LY3537982	PK: F of LY3537982	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, MD, PhD, Loxo Oncology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: June 4, 2023
• First Submitted That Met QC Criteria: June 4, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LOXO-RAS-23003; J3M-OX-JZQE (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