A Study of LY3473329 in Healthy Japanese Participants

Eli Lilly and Company24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3473329DRUG

Administered orally.

PlaceboDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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) \[Lp(a)\].

Locations (1)

Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline through Day 43

Secondary Outcomes

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

PK: AUC of LY3473329

Time frame: Predose on Day 1 through Day 43

PK: Maximum Concentration (Cmax) of LY3473329

PK: Cmax of LY3473329

Time frame: Predose on Day 1 through Day 43

PK: Time to Maximum Concentration (Tmax) of LY3473329

PK: Tmax of LY3473329

Time frame: Predose on Day 1 through Day 43

Data from ClinicalTrials.gov

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