A Study of LY3473329 in Healthy Japanese Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Investigator- and Participant-Blind, Placebo-Controlled Study of LY3473329 Multiple-Ascending Dosing in Healthy Japanese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038787
• Other study ID #: 18097
• Secondary ID: J2O-JE-EKBB
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2021
• Est. completion date: April 7, 2022

Study information

• Verified date: June 9, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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)].

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3473329
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329	PK: AUC of LY3473329	Predose on Day 1 through Day 43
Secondary	PK: Maximum Concentration (Cmax) of LY3473329	PK: Cmax of LY3473329	Predose on Day 1 through Day 43
Secondary	PK: Time to Maximum Concentration (Tmax) of LY3473329	PK: Tmax of LY3473329	Predose on Day 1 through Day 43