A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants
Non-alcoholic Steatohepatitis
About this trial
This is an interventional treatment trial for Non-alcoholic Steatohepatitis focused on measuring Non-alcoholic fatty liver disease, Glucagon-like peptide-1 (GLP-1) receptor
Eligibility Criteria
Inclusion Criteria: Healthy male and female participants of age 18 to 55 years. Females must have a negative pregnancy test. Have a Body Mass Index (BMI) of ≥ 18 and ≤ 29.9 kg/m^2. Exclusion Criteria: History or presence of any clinically significant disease or disorder. History or presence of gastrointestinal, hepatic or renal disease, or any other condition (including gastrointestinal surgery) known to interfere with absorption, distribution, metabolism, or excretion of drugs. History of acute or chronic pancreatitis. Family history of sudden cardiac death before the age of 50 of a first-degree relative. History of additional risk factors for Torsade de Pointes (eg, heart failure, clinically important bradycardia and electrolyte disturbances eg, hypokalemia, hypocalcemia, hypomagnesemia or family history of long QT syndrome). History of neoplastic disease Any clinically significant abnormalities in clinical chemistry, hematology, urinalysis results or vital signs. Any clinically significant abnormalities in rhythm, conduction, or morphology of the 12-lead resting electrocardiogram (ECG). Any positive result on screening for serum hepatitis B surface antigen OR anti-HBc antibody, indicative of active hepatitis B (ie, participants with positive anti-HBc antibody result are acceptable if anti HBc IgM antibodies are negative), hepatitis C antibody, and Human immunodeficiency virus (HIV) antibody. Current smokers or those who have smoked or used nicotine products (including e-cigarettes). Known or suspected history of alcohol or drug abuse or excessive intake of alcohol. Use of drugs with enzyme-inducing properties such as St John's Wort. Participant has a positive test result for SARS-CoV-2 RT-PCR during screening period or at baseline. Participant has clinical signs and symptoms consistent with COVID-19 or a history of severe COVID-19 (hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm 1
Arm 2A
Arm 2B
Participants will receive cotadutide and will receive a single dose of moxifloxacin-placebo on Day 1 and Day 93.
Participants will receive a single dose of moxifloxacin (Day 1) prior to initiating treatment with cotadutide-placebo for up to 13 weeks, followed by a single dose of moxifloxacin-placebo on Day 93.
Participants will receive a single dose of moxifloxacin-placebo (Day 1) prior to initiating treatment with cotadutide-placebo for up to 13 weeks, followed by a single dose of moxifloxacin on Day 93.