Double-Blind, Crossover TQT study of Tideglusib in Healthy Volunteers
Research type
Research Study
Full title
A Phase I, Placebo- and Positive-controlled, Crossover Study to Investigate the Effects of Tideglusib on QTc Interval in Healthy Subjects.
IRAS ID
1007096
Contact name
Alison McMorn
Contact email
Sponsor organisation
AMO Pharma Ltd
ISRCTN Number
Not registered
Research summary
This is a phase 1 study that consists of up to 5 periods. All subjects will receive tideglusib, placebo, (dummy drug) and moxifloaxcin. The order in which subjects receive these will be randomized. This study is only double-blinded to tideglusib and placebo (neither the investigators nor the subjects are aware at what period they receive tideglusib or placebo) in periods 1 to 4 only. Moxifloxacin is used as a positive control in this study (it is known to have the effect that is being investigated in the study drug). The study is a crossover study meaning each subject will participate in each period. Healthy male and female subjects will participate in the study.\n\nPotential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Up to 30 subjects will be enrolled to ensure that 22 subjects complete at least Periods 1 to 4, and that approximately 6 subjects complete Periods 1 to 5. \n\nOn the morning of Day 1 of Periods 1 to 4, all subjects will receive one of the following treatments, according to the randomization schedule: \n\n• 1000 mg tideglusib under fasted conditions \n• 1000 mg tideglusib under fed conditions using a high-fat breakfast \n• 400 mg moxifloxacin (positive control) under fasted conditions \n• Placebo under fasted conditions, or \n• Placebo under fed conditions using a high-fat breakfast. \n\nNote: all subjects will be randomized 1:1 to receive placebo in fasted or fed conditions using a high-fat breakfast. \n\nOn the morning of Day 1 of Period 5, approximately 6 subjects will receive: \n\n• 1000 mg tideglusib under fed conditions using a low-fat breakfast. \n\nFor each period, subjects will be discharged from the clinical research unit on Day 2 (24 hours post-dose). There will be a washout of at least 7 days between dosing occasions. \n\nSubjects will return for a follow-up visit 5 to 7 days after the final dose.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0441
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion