A Study of LY3478045 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3478045; Drug: Atorvastatin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04270370

17537

J2M-MC-GZKA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.

This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy participants as determined through medical history and physical examination
• Have a body mass index 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 3 months prior to screening and enrollment (less than [<]5 percent [%] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment
• Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator

Exclusion criteria

• Have a history of fructosuria
• 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 (QT) data analysis
• Have blood pressure 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
• Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 6 patient groups, including a placebo group

LY3478045 (Part A)

Experimental group

Description:

Participants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1.

Treatment:

Drug: LY3478045

Placebo (Part A)

Placebo Comparator group

Description:

Participants received single oral dose of placebo on Day 1.

Treatment:

Drug: Placebo

LY3478045 (Part B)

Experimental group

Description:

Participants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days.

Treatment:

Drug: LY3478045

Placebo (Part B)

Placebo Comparator group

Description:

Participants received oral dose of placebo QD for 14 days.

Treatment:

Drug: Placebo

LY3478045 + Atorvastatin (Part B)

Experimental group

Description:

Participants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.

Treatment:

Drug: Atorvastatin

Drug: LY3478045

Placebo + Atorvastatin (Part B)

Placebo Comparator group

Description:

Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.

Treatment:

Drug: Placebo

Drug: Atorvastatin