NCT05668936

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Cotadutide	Participants will receive a subcutaneous injection of cotadutide.
DRUG	Cotadutide-placebo	Participants will receive a subcutaneous injection of cotadutide-placebo.
DRUG	Moxifloxacin	Participants will receive a single oral dose of Moxifloxacin film-coated tablet.
DRUG	Moxifloxacin-placebo	Participants will receive a single oral dose of Moxifloxacin-placebo film-coated tablet.

Timeline

• Start date: 2023-01-03
• Primary completion: 2023-03-10
• Completion: 2023-03-10
• First posted: 2022-12-30
• Last updated: 2023-04-05

Locations

1 site across 1 country: Germany