Status:

COMPLETED

A Study Comparing Different Formulations of LY3410738 in Healthy Adult Participants

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

Loxo Oncology, Inc.

Conditions:

Healthy

Eligibility:

All Genders

18-55 years

Phase:

PHASE1

Brief Summary

The main purpose of study is to compare different formulations of LY3410738 under fasting condition by looking at the amount of the study drug, LY3410738, that gets into the blood stream and how long ...

Eligibility Criteria

Inclusion

  • Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
  • Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator.
  • Female participants of non-childbearing potential and male participants who follow standard contraceptive methods.
  • Must have comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call.

Exclusion

  • History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor.
  • Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening.
  • Positive polymerase chain reaction (PCR) test for COVID-19 at Screening.
  • 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 (or designee).
  • Have previously received LY3410738 in any other study investigating LY3410738, within 30 days prior to Day 1.
  • Have history of a major surgical procedure within 30 days prior to Screening.

Key Trial Info

Start Date :

October 11 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 28 2022

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06181084

Start Date

October 11 2021

End Date

April 28 2022

Last Update

December 26 2023

Active Locations (1)

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1

Labcorp Clinical Research

Daytona Beach, Florida, United States, 32117