A Study of LY3522348 in Healthy Participants

Healthy Clinical Trial

Official title:

A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single- and Multiple-Ascending Doses of LY3522348 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559568
• Other study ID #: 17808
• Secondary ID: J2U-MC-YBAA
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: August 17, 2021

Study information

• Verified date: September 2021
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 17, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3522348
Administered orally.
• Placebo
Administered orally.
• Midazolam
Administered orally to some participants.

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

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 28
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3522348	PK: AUC of LY3522348	Part A: Day 1 and Part B: Day 1 up to 144 hours post-last dose
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of LY3522348	PK: Cmax of LY3522348	Part A: Day 1 and Part B: Day 1 up to 144 hours post-last dose