CClinicalTrials.gg
CompletedNCT06181045Updated Dec 26, 2023

A Study of LY3410738 in Healthy Adult Participants

A Phase 1 interventional study of LY3410738 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Aug 2021, 5 years 2 months ago, and no results have been posted to the registry.
  • Registered 2 years 9 months after the study started (first participant enrolled Feb 2021, registered Dec 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Cohort 1 (Treatment A): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.

    Drug: LY3410738 · Drug: Placebo

  • Placebo comparator
    Cohort 2 (Treatment B): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.

    Drug: LY3410738 · Drug: Placebo

  • Experimental
    Cohort 3 (Treatment C): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

    Drug: LY3410738 · Drug: Placebo

  • Experimental
    Cohort 4 (Treatment D): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

    Drug: LY3410738 · Drug: Placebo

  • Experimental
    Cohort 5 (Treatment E): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

    Drug: LY3410738 · Drug: Placebo

  • Experimental
    Cohort 6 (Treatment F): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

    Drug: LY3410738 · Drug: Placebo

  • Experimental
    Cohort 7 (Treatment G): LY3410738

    Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.

    Drug: LY3410738 · Drug: Placebo

Interventions

  • DrugLY3410738

    Administered orally.

  • DrugPlacebo

    Administered orally.

06

What researchers measure

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

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

    Time frame: Baseline through 53 days

Secondary outcomes

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

    PK: AUC0-24 of LY3410738

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

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

    PK: AUC0-t of LY3410738

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

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

    PK: Cmax of LY3410738

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

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

    PK: Tmax of LY3410738

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

07

Study locations

2 sites
  • Covance Clinical Research Unit
    Daytona Beach, Florida 32117, United States
  • Covance Clinical Research Unit
    Madison, Wisconsin 53704, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06181045
Lead sponsor
Eli Lilly and Company
Collaborators
Loxo Oncology, Inc.
Responsible party
Sponsor
First posted
Dec 26, 2023
Start date
Feb 24, 2021
Primary completion
Aug 4, 2021
Completion
Aug 4, 2021
Last update
Dec 26, 2023

Study contacts

Yingying Guo-Avrutin
study director · Loxo Oncology, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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