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

NCT ID: NCT05668936

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-03-10

Brief Summary

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

Detailed Description

This study will be a randomized, double-blind, placebo-controlled 3-arm parallel study with a nested crossover design for positive control with moxifloxacin administration in healthy male and female participants.

Participants will be randomized to receive treatment with either cotadutide during the 13-week treatment period (Arm 1) or cotadutide-placebo (Arm 2).

The cotadutide-placebo treatment arm will be further divided into 2 subgroups (Arms 2A and 2B), in a nested crossover design for only the placebo-treated participants.

Participants will be randomized in a 2:1:1 ratio to Arm 1, Arm 2A, and Arm 2B.

Approximately 80 participants will be randomized to have 64 evaluable participants in the study.

Each participant will be involved in the study for approximately 22 weeks.

Conditions

Non-alcoholic Steatohepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

Participants will receive cotadutide and will receive a single dose of moxifloxacin-placebo on Day 1 and Day 93.

Group Type: EXPERIMENTAL

Cotadutide

Intervention Type: DRUG

Participants will receive a subcutaneous injection of cotadutide.

Moxifloxacin-placebo

Intervention Type: DRUG

Participants will receive a single oral dose of Moxifloxacin-placebo film-coated tablet.

Arm 2A

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.

Group Type: EXPERIMENTAL

Cotadutide-placebo

Intervention Type: DRUG

Participants will receive a subcutaneous injection of cotadutide-placebo.

Moxifloxacin

Intervention Type: DRUG

Participants will receive a single oral dose of Moxifloxacin film-coated tablet.

Moxifloxacin-placebo

Intervention Type: DRUG

Participants will receive a single oral dose of Moxifloxacin-placebo film-coated tablet.

Arm 2B

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.

Group Type: EXPERIMENTAL

Cotadutide-placebo

Intervention Type: DRUG

Participants will receive a subcutaneous injection of cotadutide-placebo.

Moxifloxacin

Intervention Type: DRUG

Participants will receive a single oral dose of Moxifloxacin film-coated tablet.

Moxifloxacin-placebo

Intervention Type: DRUG

Participants will receive a single oral dose of Moxifloxacin-placebo film-coated tablet.

Interventions

Cotadutide

Participants will receive a subcutaneous injection of cotadutide.

Intervention Type: DRUG

Cotadutide-placebo

Participants will receive a subcutaneous injection of cotadutide-placebo.

Intervention Type: DRUG

Moxifloxacin

Participants will receive a single oral dose of Moxifloxacin film-coated tablet.

Intervention Type: DRUG

Moxifloxacin-placebo

Participants will receive a single oral dose of Moxifloxacin-placebo film-coated tablet.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2022-002479-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D5671C00010

Identifier Type: -

Identifier Source: org_study_id