A randomized, single-dose, single blind, placebo controlled, cross over, validation study of moxifloxacin induced QT/QTc changes in healthy subjects of Indian origin (Indian subcontinent)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- QT changes as asseseed by ECG reading at
Study Overview
Brief Summary
This is a randomized, single-dose, single blind, placebo controlled, cross over study in healthy subjects. All eligible subjects will participate in a screening period (up to 21 days), two baseline visit, two ECG baseline visits (Day -1) and two single dose treatment periods with a wash out period of 7 days between dosing. An end-of-study evaluation will be conducted 5-7 days after the last dose. The central reader of ECGs will be blinded with regard to time, subject, treatment and period identification.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and/or female subjects, from 18-55 years of age and in good health.
- •Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.5 to 32 kg/m2
- •Female subjects must be: Surgically sterilized at least 6 months prior to study participation or Post-menopausal or must be using two acceptable barrier methods of contraception.
Exclusion Criteria
- •Use of any prescription drug
- •Participation in any clinical investigation
- •QTcF at screening prolonged and past medical history of clinically significant ECG abnormalities
- •Donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
- •Significant illness within the 2 weeks prior to initial dosing
- •History of or presence of risk factors for Torsade de pointes (TdP), including a family history of arrhythmia or sudden death, hypokalemia, hypomagnesia, family history of long QT syndrome
- •History of diabetes mellitus
- •History of hyperthyroidismOther exclusion critirea from protocol is applicable.
Outcomes
Primary Outcomes
QT changes as asseseed by ECG reading at
Time Frame: Screening*, baseline* (Day -2), ECG baseline (Day -1): equivalent pre-dose (8-10am) and 1, 1.5, 2, 3, 4, 6, and 12 hours post-dose; Day 1: pre-dose (24 hour post dose for Day -1)and the post-dose time points of: 1, 1.5, 2, 3, 4, 6,12 and 24 hours and end of study*.
Secondary Outcomes
- To investigate the change from baseline in the ECG morphology(Mean difference in QTcB and other QTc parameters)