A Study of LY3410738 in Healthy Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181045
• Other study ID #: LOXO-IDH-20003
• Secondary ID: I9Y-OX-JDHD
• Status: Completed
• Phase: Phase 1
• Start date: February 24, 2021
• Est. completion date: August 4, 2021

Study information

• Verified date: December 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3410738
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Daytona Beach	Florida
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline through 53 days
Secondary	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	Pre-dose up to 24 hours post-dose
Secondary	PK: Area Under the Concentration-time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of LY3410738	PK: AUC0-t of LY3410738	Pre-dose up to 48 hours post-dose
Secondary	PK: Maximum Observed Plasma Concentration (Cmax) of LY3410738	PK: Cmax of LY3410738	Pre-dose up to 48 hours post-dose
Secondary	PK: Time to Maximum Observed Plasma Concentration (Tmax) of LY3410738	PK: Tmax of LY3410738	Pre-dose up to 48 hours post-dose