Clinical trial NCT04648865: A Study of LY3537031 in Healthy Participants
Official title: A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3537031 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.


Eligibility criteria: Inclusion Criteria:

* Are male or female not of childbearing potential
* Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg)
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for blood sampling

Exclusion Criteria:

* 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 a diagnosis or history of cancer or malignant disease within 5 years
* Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening
* Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
* Have undergone any form of bariatric surgery
* Have previously completed or withdrawn from this study
* Are currently participating in or completed a clinical trial within the last 3 months
* Regularly use known drugs of abuse or with positive drug results
* Smoke \>10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission

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 at approximately Day 43
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031
timeFrame: Baseline through final follow-up at approximately Day 43
measure: PK: Maximum Concentration (Cmax) of LY3537031
timeFrame: Baseline through final follow-up at approximately Day 43
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Clinical Research Hospital Tokyo
state: Tokyo
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: