Study Results
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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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2021-02-24
2021-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Cohort 1 (Treatment A): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Cohort 2 (Treatment B): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Cohort 3 (Treatment C): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Cohort 4 (Treatment D): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Cohort 5 (Treatment E): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Cohort 6 (Treatment F): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Cohort 7 (Treatment G): LY3410738
Single oral dose of LY3410738 or placebo administered as over-encapsulated capsule or tablet formulation.
LY3410738
Administered orally.
Placebo
Administered orally.
Interventions
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LY3410738
Administered orally.
Placebo
Administered orally.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Loxo Oncology, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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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
Covance Clinical Research Unit
Madison, Wisconsin, United States
Countries
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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
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