Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2016
Source ID: NCT01984827
Associated Drug: Moxifloxacin
Title: Effect of Glucose on QTc Interval in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes
Interventions: DRUG: Moxifloxacin|OTHER: hyper-glycaemic clamp
Outcome Measures: Primary: ECG Analysis, * The paired PK and QTc interval parameters pre-dose compared to post-administration of glucose. Clinically significant ECG morphology and interval changes from baseline. * The effect on QTc will be calculated using concentration-effect analysis., 1, 2, 3 Days | Secondary: Proportion of Participants with Adverse Events, Haematology, chemistry and urinalysis will be used to assess the proportion of subjects with clinically significant changes in laboratory safety tests. Electrocardiogram (ECG) will be used to assess the proportion of subjects with morphological heart and/or heart rhythm abnormalities. PR, QRS, QT and QTc intervals will be used to assess the proportion of subjects with clinically significant changes in ECG time intervals. Systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature will be used to assess the proportion of subjects with clinically significant changes in vital signs. All of the above will be used to measure the incidence of adverse events (AEs)., 1, 2, 3 Days
Sponsor/Collaborators: Sponsor: Richmond Research Institute | Collaborators: Richmond Pharmacology Limited
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-02-10
Completion Date: 2020-12-31
Results First Posted:
Last Update Posted: 2021-05-05
Locations: Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge, London, SE1 1YR, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01984827