NCT05824858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

April 11, 2023

Last Update Submit

September 28, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC[0-inf])

    PK: AUC(0-inf)

    Day 1 and Day 4 of each study period

  • PK: Maximum Observed Concentration (Cmax) of LY3537982

    PK: Cmax of LY3537982

    Day 1 and Day 4 of each study period

Study Arms (2)

LY3537982 (High-Fat Meal)

EXPERIMENTAL

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

LY3537982 (Low-Fat Meal)

EXPERIMENTAL

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

Interventions

LY3537982DRUG

Administered orally.

LY3537982 (High-Fat Meal)LY3537982 (Low-Fat Meal)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICON

Salt Lake City, Utah, 84124, United States

Location

Study Officials

  • Yingying Guo-Avrutin, MD, PhD

    Loxo Oncology, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

April 12, 2023

Primary Completion

June 17, 2023

Study Completion

June 17, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)