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OpenTrials
Completed

NCT Number: NCT06181045

A Study of LY3410738 in Healthy Adult Participants

The main purpose of this study is to assess the safety and tolerability of LY3410738 and to look at the amount of the study drug, LY3410738, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 53 days, including screening.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Daytona Beach, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), 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 comply with all study procedures, including the 3-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion criteria

  • 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

Treatment and study plan

LY3410738

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

  1. Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline through 53 days

    A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738

    Time frame: Pre-dose up to 24 hours post-dose

    PK: AUC0-24 of LY3410738

  2. PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738

    Time frame: Pre-dose up to 48 hours post-dose

    PK: AUC0-t of LY3410738

  3. PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738

    Time frame: Pre-dose up to 48 hours post-dose

    PK: Cmax of LY3410738

  4. PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738

    Time frame: Pre-dose up to 48 hours post-dose

    PK: Tmax of LY3410738

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Loxo Oncology, Inc.

Registry information

Official study title

A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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