A Study of LY3461767 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352114
• Other study ID #: 17517
• Secondary ID: J2L-MC-EZBA
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2020
• Est. completion date: January 13, 2021

Study information

• Verified date: February 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 13, 2021
• Est. primary completion date: January 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3461767 - SC
Administered SC.
• LY3461767 - IV
Administered IV.
• Placebo - SC
Administered SC.

Locations

Country	Name	City	State
Singapore	Lilly Nus Centre for Clin Pharmacology	Singapore
United States	Covance Dallas	Dallas	Texas
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 29
Secondary	Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767	PK: Cmax of LY3461767	Baseline through Day 29
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767	PK: AUC of LY3461767	Baseline through Day 29