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

• Status: Not yet recruiting
• Trial end date: 2023-10-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

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).