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

NCT ID: NCT05901311

Last Updated: 2024-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-05

Study Completion Date

2023-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

[¹⁴C]-LY3537982 (Part 1)

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

Group Type EXPERIMENTAL

[¹⁴C]-LY3537982

Intervention Type DRUG

Administered orally.

[¹⁴C]-LY3537982 + LY3537982 (Part 2)

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

Group Type EXPERIMENTAL

LY3537982

Intervention Type DRUG

Administered orally.

[¹⁴C]-LY3537982

Intervention Type DRUG

Administered IV.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY3537982

Administered orally.

Intervention Type DRUG

[¹⁴C]-LY3537982

Administered orally.

Intervention Type DRUG

[¹⁴C]-LY3537982

Administered IV.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Olomorasib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Loxo Oncology, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yingying Guo-Avrutin, MD, PhD

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Labcorp Clinical Research Unit Inc.

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

J3M-OX-JZQE

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-RAS-23003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of LYL314 in Aggressive Large B-Cell Lymphoma
NCT05826535 RECRUITING PHASE1/PHASE2
A Study of LY2584702 in Solid Tumors
NCT01241461 COMPLETED PHASE1
Axicabtagene Ciloleucel Expanded Access Study
NCT03153462 APPROVED_FOR_MARKETING