Status:
COMPLETED
A Study of LY3540378 in Healthy Participants
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
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 B) and multiple ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04768855
Start Date
March 17 2021
End Date
May 30 2022
Last Update
June 21 2022
Active Locations (2)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
2
Lilly Centre for Clinical Pharmacology
Singapore, Singapore, 138623