A Study of the Effect of Food on LY3537982 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05824858

Collaborator

Loxo Oncology, Inc. (Industry)

Enrollment

Arms

1.7

Anticipated Duration (Months)

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 after meals and on an empty stomach. The study will also evaluate the safety and tolerability of LY3537982. Participants will stay in the research center during the study, which will last about one week, not including screening.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3537982	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1 Study to Evaluate the Effect of Food on the LY3537982 Pharmacokinetics in Health Adult Subjects

Anticipated Study Start Date :

Apr 11, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3537982 (High-Fat Meal) LY3537982 administered orally under fasting conditions in one study period and under fed conditions (i.e., a standard high-fat meal) in the other study period.	Drug: LY3537982 Administered orally.
Experimental: LY3537982 (Low-Fat Meal) LY3537982 administered orally under fasting conditions in one study period and under fed conditions (i.e., a standard low-fat meal) in the other study period.	Drug: LY3537982 Administered orally.

Arm

Intervention/Treatment

Experimental: LY3537982 (High-Fat Meal)

LY3537982 administered orally under fasting conditions in one study period and under fed conditions (i.e., a standard high-fat meal) in the other study period.

Drug: LY3537982

Administered orally.

Experimental: LY3537982 (Low-Fat Meal)

LY3537982 administered orally under fasting conditions in one study period and under fed conditions (i.e., a standard low-fat meal) in the other study period.

Drug: LY3537982

Administered orally.

Outcome Measures

Primary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf]) [Day 1 and Day 4 of each study period]
PK: AUC(0-inf)
PK: Maximum Observed Concentration (Cmax) of LY3537982 [Day 1 and Day 4 of each study period]
PK: Cmax 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:

Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

Females who are lactating or of childbearing potential
Clinically significant history of any drug sensitivity, drug allergy, or food allergy

Contacts and Locations

Locations

No locations specified.

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:

NCT05824858

Other Study ID Numbers:

LOXO-RAS-23006
J3M-OX-JZQI

First Posted:

Apr 24, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 24, 2023