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Recruiting NCT05668936

A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants

Conditions: Non-alcoholic Steatohepatitis

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 80
Sponsor: AstraZeneca

Location: Germany

Summary

This study will investigate the effect of multiple doses of cotadutide on the cardiac activity (QTc interval) of healthy participants.

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 diseaseAny 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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05668936). StuddyBuddy aggregates publicly available trial information.