A thorough QTC study to assess the effect of Cotadutide on cardiac repolarization in healthy participants

Study identifier:D5671C00010

ClinicalTrials.gov identifier:NCT05668936

EudraCT identifier:2022-002479-12

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

A Thorough QTc Evaluation of the Effect of Cotadutide on Cardiac Repolarization in Healthy Participants: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel Study with a Nested Crossover Design for Positive Control with Moxifloxacin Administration

Medical condition

non-alcoholic steatohepatitis

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Cotadutide, Cotadutide-placebo, Moxifloxacin, Moxifloxacin-placebo

Sex

All

Actual Enrollment

31

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 03 Jan 2023
Primary Completion Date: 10 Mar 2023
Study Completion Date: 10 Mar 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria