A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Part… (NCT05668936) | Clinical Trial Compass
TerminatedPhase 1
A Thorough QTC Study to Assess the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants
Stopped: Discontinuing the development of cotadutide, a daily injectable GLP-1/glucagon co-agonist, is based on strategic pipeline considerations. The premature closure is not due to any newly observed safety signals or a change in the risk/benefit profile.
Germany31 participantsStarted 2023-01-03
Plain-language summary
This study will investigate the effect of multiple doses of cotadutide on the cardiac activity (QTc interval) of healthy participants.
Who can participate
Age range18 Years – 55 Years
SexALL
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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 nic…
What they're measuring
1
Time-matched change-from-baseline Fridericia's correction of QT interval (QTcF)