Clinical trial NCT04270370: A Study of LY3478045 in Healthy Participants
Official title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single-and Multiple Ascending Doses of LY3478045in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.

This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy participants as determined through medical history and physical examination
* Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
* Have had a stable weight for 3 months prior to screening and enrollment (less than \[\<\]5 percent \[%\] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment
* Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator

Exclusion Criteria:

* Have a history of fructosuria
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis
* Have blood pressure greater than (\>)160/90 millimeters of mercury (mmHg) and pulse rate \<50 or \>100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
* Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study

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 Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045
timeFrame: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose
measure: PK: Maximum Concentration (Cmax) of LY3478045
timeFrame: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas
state: Texas
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: