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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05901311
• Collaborator: Loxo Oncology, Inc. (Industry)
• Enrollment: 16
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1.9
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3537982; Drug: [¹⁴C]-LY3537982; Drug: [¹⁴C]-LY3537982	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Anticipated Study Start Date: Jun 5, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [¹⁴C]-LY3537982 (Part 1) Single dose of [¹⁴C]-LY3537982 administered orally.	Drug: [¹⁴C]-LY3537982; Administered orally.
Experimental: [¹⁴C]-LY3537982 + LY3537982 (Part 2) Single dose of LY3537982 administered orally followed by [¹⁴C]-LY3537982 administered intravenously (IV).	Drug: LY3537982; Administered orally.; Drug: [¹⁴C]-LY3537982; Administered IV.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Fraction of Dose Excreted in Urine (Feur) [Predose on day 1 up to postdose on day 21 (Part 1)]

   PK: Feur

2. PK: Cumulative Feur [Predose on day 1 up to postdose on day 21 (Part 1)]

   PK: Cumulative Feur

3. PK: Fraction of Dose Excreted in Feces (Fefeces) [Predose on day 1 up to postdose on day 21 (Part 1)]

   PK: Fefeces

4. PK: Cumulative Fefeces [Predose on day 1 up to postdose on day 21 (Part 1)]

   PK: Cumulative Fefeces

5. PK: Fraction of Dose Excreted in Expired Air (Feair) [Predose on day 1 up to postdose on day 21 (Part 1)]

   PK: Feair

6. PK: Absolute Bioavailability (F) of LY3537982 [Predose on day 1 up to postdose on day 9 (Part 2)]

   PK: F of LY3537982

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit Inc.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Eli Lilly and Company
• Loxo Oncology, Inc.

Investigators

• Study Director: Yingying Guo-Avrutin, MD, PhD, Loxo Oncology, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT05901311
• Other Study ID Numbers: LOXO-RAS-23003; J3M-OX-JZQE
• First Posted: Jun 13, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 13, 2023