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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05824858
Enrollment
48
Registered
2023-04-24
Start date
2023-04-12
Completion date
2023-06-17
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

Administered orally.

Sponsors

Loxo Oncology, Inc.
CollaboratorINDUSTRY
Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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 periodPK: AUC(0-inf)
PK: Maximum Observed Concentration (Cmax) of LY3537982Day 1 and Day 4 of each study periodPK: Cmax of LY3537982

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026