A Study of LY3478045 in Healthy Participants

NCT04270370 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17537J2M-MC-GZKA
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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, is reported in the Reported Adverse Events module.

  Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)

Secondary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045

  Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose

• PK: Maximum Concentration (Cmax) of LY3478045

  Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose

Study Arms (6)

LY3478045 (Part A)

EXPERIMENTAL

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

Drug: LY3478045

Placebo (Part A)

PLACEBO COMPARATOR

Participants received single oral dose of placebo on Day 1.

Drug: Placebo

LY3478045 (Part B)

EXPERIMENTAL

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

Drug: LY3478045

Placebo (Part B)

PLACEBO COMPARATOR

Participants received oral dose of placebo QD for 14 days.

Drug: Placebo

LY3478045 + Atorvastatin (Part B)

EXPERIMENTAL

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.

Drug: LY3478045; Drug: Atorvastatin

Placebo + Atorvastatin (Part B)

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Atorvastatin

Interventions

LY3478045 DRUG

Administered orally.

LY3478045 (Part A); LY3478045 (Part B); LY3478045 + Atorvastatin (Part B)

Placebo DRUG

Administered orally.

Placebo (Part A); Placebo (Part B); Placebo + Atorvastatin (Part B)

Atorvastatin DRUG

Administered orally.

LY3478045 + Atorvastatin (Part B); Placebo + Atorvastatin (Part B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: March 16, 2020
• Primary Completion: June 23, 2021
• Study Completion: June 23, 2021
• Last Updated: July 25, 2024
• Results First Posted: July 25, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)