A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Participant-and Investigator-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose, Drug-Drug Interaction and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3509754 in Healthy Non-Japanese and Japanese Participants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04586920
• Other study ID #: 17797
• Secondary ID: J3D-MC-FNAA2020-
• Status: Terminated
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: October 14, 2022

Study information

• Verified date: December 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 104
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Overtly healthy males or females, as determined by medical history and physical examination.
• Body mass index (BMI) within the range of 18 to 35 kilograms per meter squared (kg/m²) in Parts A, B, and C. In Part D (Japanese participants), body weight between 50 and 85 kg and BMI within the range of 18 to 28 kg/m².

Exclusion Criteria:

• Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.
• Women of childbearing potential are excluded from the trial.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3509754
Administered orally
• Placebo
Administered orally
• Itraconazole
Administered orally
• Midazolam
Administered orally

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	Covance Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline up to Day 34
Secondary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754	PK: Cmax of LY3509754	Predose up to 96 hours postdose
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3509754	PK: AUC of LY3509754	Predose up to 96 hours postdose