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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901311
• Other study ID #: LOXO-RAS-23003
• Secondary ID: J3M-OX-JZQE
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: September 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3537982
Administered orally.
• [¹4C]-LY3537982
Administered orally.
• [¹4C]-LY3537982
Administered IV.

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur)	PK: Feur	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Cumulative Feur	PK: Cumulative Feur	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Fraction of Dose Excreted in Feces (Fefeces)	PK: Fefeces	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Cumulative Fefeces	PK: Cumulative Fefeces	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Fraction of Dose Excreted in Expired Air (Feair)	PK: Feair	Predose on day 1 up to postdose on day 21 (Part 1)
Primary	PK: Absolute Bioavailability (F) of LY3537982	PK: F of LY3537982	Predose on day 1 up to postdose on day 9 (Part 2)