A Study of LY3522348 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Midazolam; Drug: Placebo; Drug: LY3522348

Study type: Interventional

Funder types: Industry

Identifiers

NCT04559568

J2U-MC-YBAA (Other Identifier)

17808 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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65 participants in 11 patient groups, including a placebo group

Part A: Placebo

Placebo Comparator group

Description:

A single dose of Placebo administered orally on Day 1.

Treatment:

Drug: Placebo

Part A: 5 milligrams (mg) LY3522348

Experimental group

Description:

A single dose of 5 mg LY3522348 administered orally on Day 1.

Treatment:

Drug: LY3522348

Part A: 15 mg LY3522348

Experimental group

Description:

A single dose of 15 mg LY3522348 administered orally on Day 1.

Treatment:

Drug: LY3522348

Part A: 50 mg LY3522348

Experimental group

Description:

A single dose of 50 mg LY3522348 administered orally on Day 1.

Treatment:

Drug: LY3522348

Part A: 150 mg LY3522348

Experimental group

Description:

A single dose of 150 mg LY3522348 administered orally on Day 1.

Treatment:

Drug: LY3522348

Part A: 380 mg LY3522348

Experimental group

Description:

A single dose of 380 mg LY3522348 administered orally on Day 1.

Treatment:

Drug: LY3522348

Part B: Placebo

Placebo Comparator group

Description:

Placebo administered orally once daily on Days 1-14.

Treatment:

Drug: Placebo

Part B: Placebo + Midazolam

Experimental group

Description:

Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15.

Treatment:

Drug: Placebo

Drug: Midazolam

Part B: 50 mg LY3522348

Experimental group

Description:

50 mg LY3522348 administered orally once daily on Days 1-14.

Treatment:

Drug: LY3522348

Part B: 120 mg LY3522348

Experimental group

Description:

120 mg LY3522348 administered orally once daily on Days 1-14.

Treatment:

Drug: LY3522348

Part B: 290 mg LY3522348 + Midazolam

Experimental group

Description:

290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15.

Treatment:

Drug: LY3522348

Drug: Midazolam