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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3509754; Drug: Itraconazole; Drug: Midazolam

• Registration Number: NCT04586920
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Study Start: 2020-10-20
• Primary Completion: 2022-10-14
• Study Completion: 2022-10-14
• Results First Submitted: 2024-08-02
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 104

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• Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo - Part A	Placebo	Placebo was administered orally.
LY3509754 plus Itraconazole - Part B	Itraconazole	10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.
Placebo plus Itraconazole - Part B	Placebo	Placebo and 200 mg Itraconazole were administered orally.
Placebo plus Itraconazole - Part B	Itraconazole	Placebo and 200 mg Itraconazole were administered orally.
LY3509754 plus Midazolam - Part C	LY3509754	Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.
LY3509754 plus Midazolam - Part C	Midazolam	Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.
Placebo plus Midazolam - Part C	Placebo	Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.
Placebo plus Midazolam - Part C	Midazolam	Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.
LY3509754 (Japanese) - Part D	LY3509754	Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants.
Placebo (Japanese) - Part D	Placebo	Placebo was administered orally to Japanese participants.
LY3509754 - Part A	LY3509754	Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally.
LY3509754 plus Itraconazole - Part B	LY3509754	10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.

Primary Outcome Measures

Name	Time	Method
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 26	An SAE is any adverse event (AE) from the study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent 1 of the other outcomes listed in the definition above.; The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3509754 in Parts A and B	Part A: Pre-dose (P), 0.5,1,2,3,4,5,6,8,12,16,24,36,48,72,96 hours (h) post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24,36,48,72,96,120,144,168 h Post Day 10 dose.	PK: Cmax of LY3509754 in Parts A and B.
PK: Cmax of LY3509754 in Parts C and D	Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24,48,72,96 h Post Day 14 dose.	PK: Cmax of LY3509754 in Parts C and D.
PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose AUC(0-24) of LY3509754 in Parts A and B	Part A: P, 0.5,1,2,3,4,5,6,8,12,16,24 h post Day 1 dose. Part B: P,0.5,1,2,3,4,6,8,12,16,24 h post Day 1 dose; P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 10 dose.	PK: AUC(0-24) of LY3509754 in Parts A and B.
PK: AUC(0-24) of LY3509754 in Parts C and D	Part C-Cohorts 1 and 3: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose. Part C-Cohort 2: P,0.5,1,2,3,4,5,6,8,12,16,24 h Post Day 14 dose. Part D: P,0.5,1,2,3,4,6,8,12,16,24 h Post Day 14 dose.	PK: AUC(0-24) of LY3509754 in Parts C and D.

Trial Locations

Locations (2)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

Covance Dallas; 🇺🇸 Dallas, Texas, United States