Study identifier:D5671C00010
ClinicalTrials.gov identifier:NCT05668936
EudraCT identifier:2022-002479-12
CTIS identifier:N/A
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
non-alcoholic steatohepatitis
Phase 1
Yes
Cotadutide, Cotadutide-placebo, Moxifloxacin, Moxifloxacin-placebo
All
31
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Feb 2024 by AstraZeneca
AstraZeneca
-
This study will investigate the effect of multiple doses of cotadutide on the cardiac activity (QTc interval) of healthy participants.
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.
Location
Location
Berlin, Germany, 14050
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 Participants will receive cotadutide and will receive a single dose of moxifloxacin-placebo on Day 1 and Day 93. | Drug: Cotadutide Participants will receive a subcutaneous injection of cotadutide. Drug: Moxifloxacin-placebo Participants will receive a single oral dose of Moxifloxacin-placebo film-coated tablet. |
Experimental: 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. | 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. |
Experimental: 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. | 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. |
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