A clinical trial to study the effects of moxifloxacin on ECG readings in healthy subjects of Indian origi

Phase 1

Completed

• Registration Number: CTRI/2009/091/000332
• Lead Sponsor: ovartis Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Male and/or female subjects, from 18-55 years of age and in good health.

2. 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

3. 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

1. Use of any prescription drug
2. Participation in any clinical investigation
3. QTcF at screening prolonged and past medical history of clinically significant ECG abnormalities
4. Donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
5. Significant illness within the 2 weeks prior to initial dosing
6. 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
7. History of diabetes mellitus
8. History of hyperthyroidism
Other exclusion critirea from protocol is applicable.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
QT changes as asseseed by ECG reading atTimepoint: Screening*, baseline* (Day -2), ECG baseline (Day -1): equivalent pre-dose (8-10<br>am) and 1, 1.5, 2, 3, 4, 6, and 12 hours post-dose; Day 1: pre-dose (24 hour post dose for Day -1)<br>and the post-dose time points of: 1, 1.5, 2, 3, 4, 6,12 and 24 hours and end of study*.

Secondary Outcome Measures

Name	Time	Method
To investigate the change from baseline in the ECG morphology <br/ ><br>Mean difference in QTcB and other QTc parametersTimepoint: Based on the ECG recorded as per primary outcome