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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05901311

LOXO-RAS-23003

J3M-OX-JZQE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

[¹⁴C]-LY3537982 (Part 1)

Experimental group

Description:

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

Treatment:

Drug: [¹⁴C]-LY3537982

Drug: [¹⁴C]-LY3537982

[¹⁴C]-LY3537982 + LY3537982 (Part 2)

Experimental group

Description:

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

Treatment:

Drug: LY3537982

Drug: [¹⁴C]-LY3537982

Drug: [¹⁴C]-LY3537982