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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Suspended
• CT.gov ID: NCT04586920
• Collaborator: (none)
• Enrollment: 105
• Locations: 2
• Arms: 8
• Anticipated Duration (Months): 16.3
• Patients Per Site: 52.5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3509754; Drug: Placebo; Drug: Itraconazole; Drug: Midazolam	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Oct 20, 2020
• Anticipated Primary Completion Date: Feb 28, 2022
• Anticipated Study Completion Date: Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3509754 - Part A Escalating doses of LY3509754 administered orally	Drug: LY3509754; Administered orally
Placebo Comparator: Placebo - Part A Placebo administered orally	Drug: Placebo; Administered orally
Experimental: LY3509754 plus Itraconazole - Part B LY3509754 and Itraconazole administered orally	Drug: LY3509754; Administered orally; Drug: Itraconazole; Administered orally
Placebo Comparator: Placebo plus Itraconazole - Part B Placebo and Itraconazole administered orally	Drug: Placebo; Administered orally; Drug: Itraconazole; Administered orally
Experimental: LY3509754 plus Midazolam - Part C Multiple doses of LY3509754 administered orally. Some participants will also receive midazolam orally.	Drug: LY3509754; Administered orally; Drug: Midazolam; Administered orally
Placebo Comparator: Placebo plus Midazolam - Part C Multiple doses of placebo administered orally. Some participants will also receive midazolam orally.	Drug: Placebo; Administered orally; Drug: Midazolam; Administered orally
Experimental: LY3509754 (Japanese) - Part D Multiple doses of LY3509754 administered orally to Japanese participants	Drug: LY3509754; Administered orally
Placebo Comparator: Placebo (Japanese) - Part D Placebo administered orally to Japanese participants	Drug: Placebo; Administered orally

Outcome Measures

Primary Outcome Measures

1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline up to Day 34]

   A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 [Predose up to 96 hours postdose]

   PK: Cmax of LY3509754

2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3509754 [Predose up to 96 hours postdose]

   PK: AUC of LY3509754

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
2	Covance Dallas	Dallas	Texas	United States	75247

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04586920
• Other Study ID Numbers: 17797; J3D-MC-FNAA; 2020-003957-30
• First Posted: Oct 14, 2020
• Last Update Posted: Dec 13, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Itraconazole; Midazolam

Study Results

No Results Posted as of Dec 13, 2021