Clinical trial NCT06181045: A Study of LY3410738 in Healthy Adult Participants
Official title: A Phase 1, Single-Ascending-Dose, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3410738 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2023-12-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline through 53 days
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration-time Curve, From Time 0 to 24 Hours Post-dose (AUC0-24) of LY3410738
timeFrame: Pre-dose up to 24 hours post-dose
measure: PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738
timeFrame: Pre-dose up to 48 hours post-dose
measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738
timeFrame: Pre-dose up to 48 hours post-dose
measure: PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738
timeFrame: Pre-dose up to 48 hours post-dose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit
state: Florida
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Loxo Oncology, Inc.
name: Yingying Guo-Avrutin
role: STUDY_DIRECTOR
References: