A Study of LY3540378 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04768855
Collaborator
(none)
132
Enrollment
2
Locations
5
Arms
17.5
Anticipated Duration (Months)
66
Patients Per Site
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3540378 in healthy participants following single and multiple doses (Parts A and

  1. and multiple doses in Japanese (Part C) and Chinese (Part D) healthy participants. Blood tests will be performed to check how much LY3540378 gets into the bloodstream and how long it takes the body to eliminate it. This is a 4-part study and may last up to 70, 113, 113 and 113 days for each participant in Parts A, B, C, and D respectively.
Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3540378 in Healthy Participants
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY3540378 (Part A)

Single ascending doses of LY3540378 administered either intravenously (IV) or subcutaneously (SC).

Drug: LY3540378
Administered IV or SC.

Experimental: LY3540378 (Part B)

Multiple ascending doses of LY3540378 administered SC.

Drug: LY3540378
Administered SC.

Experimental: LY3540378 (Part C)

Multiple ascending doses of LY3540378 administered SC in Japanese Participants.

Drug: LY3540378
Administered SC.

Experimental: LY3540378 (Part D)

Multiple ascending doses of LY3540378 administered SC in Chinese Participants.

Drug: LY3540378
Administered SC.

Placebo Comparator: Placebo (Part A, B, C & D)

Placebo administered either IV or SC.

Drug: Placebo
Administered IV or SC.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline up to Day 113]

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3540378 [Predose on Day 1 through Day 113]

    PK: Cmax of LY3540378

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3540378 [Predose on Day 1 through Day 113]

    PK: AUC of LY3540378

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Overtly healthy males or females, as determined by medical history and physical examination.

  • Body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)

  • For Part C, participants should be first generation Japanese origin.

  • For Part D, participants should be first generation Chinese origin.

  • Male participants must agree to adhere to contraception restrictions and female participants not of childbearing potential and may include who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), or congenital anomaly such as müllerian agenesis or postmenopausal

Exclusion Criteria:
  • Participants with troponin I results above the upper reference limit judged to be clinically significant by the investigator

  • Diagnosed with orthostatic hypotension defined as a decrease in systolic blood pressure of 20 mm Hg or a decrease in diastolic blood pressure of 10 mm Hg within 3 minutes of standing when compared with blood pressure from the sitting or supine position.

  • Have a significant history of or current cardiovascular (for example, myocardial infarction, congestive HF, cerebrovascular accident, venous thromboembolism, etc.), respiratory, renal, gastrointestinal, endocrine, haematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs

  • Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis biliary and pancreatic disorder

  • Have evidence of significant active neuropsychiatric disease as determined by the investigator

  • Have received chronic (lasting >14 consecutive days) systemic glucocorticoid therapy in the past year, or have received any glucocorticoid therapy within 1 month before screening

  • Have an abnormality in the 12-lead ECG

  • Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × the upper limit of normal (ULN) or total bilirubin (TBL) >1.5 × ULN

  • Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase greater than 1.5 × ULN

  • Have known allergies to LY3540378 or related compounds

  • Have donated blood of >450 mL, or have participated in a clinical study that required similar blood volume drawn within the past 30 calendar days

  • Have an average weekly alcohol intake that exceeds 7 units per week, or are unwilling to stop alcohol consumption as required during the study (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)

  • Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine

  • Allergy to iodine (shellfish allergy)

  • Have a history of sensitivity to lithium carbonate

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
2Lilly Centre for Clinical PharmacologySingaporeSingapore138623

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04768855
Other Study ID Numbers:
  • 17793
  • J3E-MC-EZDA
First Posted:
Feb 24, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 15, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 18, 2021