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
-
No locations available
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. |