A Study of LY3473329 in Healthy Japanese Participants

NCT05038787 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18097J2O-JE-EKBB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to about 71 days, inclusive of screening period.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Day 43

Secondary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329

  Predose on Day 1 through Day 43

• PK: Maximum Concentration (Cmax) of LY3473329

  Predose on Day 1 through Day 43

• PK: Time to Maximum Concentration (Tmax) of LY3473329

  Predose on Day 1 through Day 43

Study Arms (2)

LY3473329

EXPERIMENTAL

LY3473329 administered orally.

Drug: LY3473329

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY3473329 DRUG

Administered orally.

LY3473329

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are overtly healthy as determined through medical history and physical examination.
• Are males who agree to follow contraception requirements or females not of childbearing potential.
• Are 1st generation Japanese defined as the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

You may not qualify if:

• Have a history or presence of medical illness.
• Have significant history of or current psychiatric disorders.
• Have abnormalities in the 12-lead ECG and blood pressure.
• Have received treatment with siRNA within the past 12 months or any antisense oligonucleotide within the past 6 months for lipoprotein(a) \[Lp(a)\].

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

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

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: September 7, 2021
• First Posted: September 9, 2021
• Study Start: November 11, 2021
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)