A Study of LY3461767 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3461767 - SC; Drug: LY3461767 - IV; Drug: Placebo - SC

• Registration Number: NCT04352114
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-20
• Study Start: 2020-06-15
• Primary Completion: 2021-01-13
• Study Completion: 2021-01-13
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Are healthy males, or females of non-child-bearing potential
• Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
• Have clinical laboratory tests within normal ranges as judged by investigator
• Have pulse rate and blood pressure within normal ranges as judged by investigator

Read More

Exclusion Criteria

• Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
• Regularly use known drugs of abuse
• Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
• Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
• Smoke more than 10 cigarettes per day
• Are current or former smokers with 30-pack-year smoking history
• Have a diagnosis or history of any malignancy
• Have not had appropriate cancer screening, in accordance with country specific guidance

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3461767 - Subcutaneous (SC)	LY3461767 - SC	LY3461767 administered SC.
LY3461767 - Intravenous (IV)	LY3461767 - IV	LY3461767 administered IV.
Placebo - SC	Placebo - SC	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Day 29	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767	Baseline through Day 29	PK: Cmax of LY3461767
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767	Baseline through Day 29	PK: AUC of LY3461767

Trial Locations

Locations (3)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States

Covance Dallas; 🇺🇸 Dallas, Texas, United States

Lilly Nus Centre for Clin Pharmacology; 🇸🇬 Singapore, Singapore