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

NCT05901311 | Completed Phase 1 FDA Drug

• 2 other identifiers: LOXO-RAS-23003J3M-OX-JZQE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 LY3537982

  PK: F of LY3537982

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

Study Arms (2)

[¹⁴C]-LY3537982 (Part 1)

EXPERIMENTAL

Single dose of \[¹⁴C\]-LY3537982 administered orally.

Drug: [¹⁴C]-LY3537982

[¹⁴C]-LY3537982 + LY3537982 (Part 2)

EXPERIMENTAL

Single dose of LY3537982 administered orally followed by \[¹⁴C\]-LY3537982 administered intravenously (IV).

Drug: LY3537982; Drug: [¹⁴C]-LY3537982

Interventions

LY3537982 DRUG

Administered orally.

Also known as: Olomorasib

[¹⁴C]-LY3537982 + LY3537982 (Part 2)

[¹⁴C]-LY3537982 DRUG

Administered orally.

[¹⁴C]-LY3537982 (Part 1)

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 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)

Labcorp Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Yingying Guo-Avrutin, MD, PhD

  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: June 4, 2023
• First Posted: June 13, 2023
• Study Start: June 5, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)