Clinical trial NCT04178733: A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants
Official title: A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3493269 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have been treated with weight loss medications within 3 months of screening

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 final follow-up (Up To Day 43)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269
timeFrame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination
measure: PK: Maximum Concentration (Cmax) of LY3493269
timeFrame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
measure: PK: Time to Maximum Concentration (Tmax) of LY3493269
timeFrame: Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Lilly Centre for Clinical 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: