Clinical trial NCT04352114: A Study of LY3461767 in Healthy Participants
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 29
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767
timeFrame: Baseline through Day 29
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767
timeFrame: Baseline through Day 29
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
city: Singapore
country: Singapore
facility: Lilly Nus Centre for Clin Pharmacology
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: