A Phase 1, Randomized, Investigator- and Participant-Blind, Placebo-Controlled Study of LY3473329 Multiple-Ascending Dosing in Healthy Japanese Participants
Overview
- Phase
- Phase 1
- Intervention
- LY3473329
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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) \[Lp(a)\].
Arms & Interventions
LY3473329
LY3473329 administered orally.
Intervention: LY3473329
Placebo
Placebo administered orally.
Intervention: Placebo
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
Time Frame: Baseline through Day 43
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcomes
- 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)