A Study of LY3522348 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3522348; Drug: Placebo; Drug: Midazolam

• Registration Number: NCT04559568
• 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 LY3522348 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3522348 gets into the bloodstream and how long it takes the body to eliminate it. This study has two parts: Part A will last up to about six weeks and Part B will last up to about eight weeks for each participant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-23
• Study Start: 2020-10-15
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Are overtly healthy as determined through medical evaluation including medical history and physical examination
• Have a body mass index of greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
• Have had a stable weight for one month prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the one month prior to screening and enrollment
• Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria

• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
• Have blood pressure of greater than (>)160/90 millimeters of mercury (mmHg) and pulse rate <50 or >100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
• Have a history of fructosuria
• Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A) is specifically excluded within 14 days prior to the first administration of study intervention and during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3522348 (Part A)	LY3522348	LY3522348 administered orally.
Placebo (Part A)	Placebo	Placebo administered orally.
LY3522348 (Part B)	LY3522348	LY3522348 administered orally. Some participants will also receive midazolam.
Placebo (Part B)	Placebo	Placebo administered orally. Some participants will also receive midazolam.
Placebo (Part B)	Midazolam	Placebo administered orally. Some participants will also receive midazolam.
LY3522348 (Part B)	Midazolam	LY3522348 administered orally. Some participants will also receive midazolam.

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 28	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

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3522348	Part A: Day 1 and Part B: Day 1 up to 144 hours post-last dose	PK: AUC of LY3522348
PK: Maximum Observed Drug Concentration (Cmax) of LY3522348	Part A: Day 1 and Part B: Day 1 up to 144 hours post-last dose	PK: Cmax of LY3522348

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States