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A Study of LY3410738 in Healthy Adult Participants

NCT ID: NCT06181045

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-24

Study Completion Date

2021-08-04

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 (Treatment A): LY3410738

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

Group Type EXPERIMENTAL

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Cohort 2 (Treatment B): LY3410738

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

Group Type PLACEBO_COMPARATOR

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Cohort 3 (Treatment C): LY3410738

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

Group Type EXPERIMENTAL

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Cohort 4 (Treatment D): LY3410738

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

Group Type EXPERIMENTAL

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Cohort 5 (Treatment E): LY3410738

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

Group Type EXPERIMENTAL

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Cohort 6 (Treatment F): LY3410738

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

Group Type EXPERIMENTAL

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Cohort 7 (Treatment G): LY3410738

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

Group Type EXPERIMENTAL

LY3410738

Intervention Type DRUG

Administered orally.

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY3410738

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Loxo Oncology, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingying Guo-Avrutin

Role: STUDY_DIRECTOR

Loxo Oncology, Inc.

Locations

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Covance Clinical Research Unit

Daytona Beach, Florida, United States

Site Status

Covance Clinical Research Unit

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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I9Y-OX-JDHD

Identifier Type: OTHER

Identifier Source: secondary_id

LOXO-IDH-20003

Identifier Type: -

Identifier Source: org_study_id