Thorough QT/QTc study for Garenoxacin - SCH 745737 QT/QTc study

Phase 1

• Conditions: MedDRA version: 8.1Level: HLTClassification code 10004047Term: Bacterial infections NEC; Indication: bacterial infections

• Registration Number: EUCTR2006-006168-46-NL
• Lead Sponsor: Schering-Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-22
• Study Completion: 2007-04-24
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Age between 18 and 55 years, inclusive
BMI between 19 to 32 kg/m2, inclusive
Free of any significant disease that would interfere with the study evaluations
ECG and vital signs withing normal ranges
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any surgical or medical conditions which might significantly alter the absorption, distribution, metabolism or excretion of any drug
History of any infectious disease within 4 weeks prior to drug administration
Positive screen for hepatitis B, hepatitis C or HIV
Positive drug screen
Mental instability or treated for mood disorders
Blood donation in past 60 days
Participation in another clinical study within 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate QT/QTc prolongation and proarrhythmic potential for garenoxacin using a placebo control and moxifloxacin as the positive control in adult healthy volunteers;Secondary Objective: to evaluate safety, tolerability and pharmacokinetics of garenoxacin at supratherapeutic doses in adult healthy volunteers;Primary end point(s): Part 1:<br>to evaluate the safety, tolerability and pharmacokinetics of garenoxacin at supra-therapeutic doses in normal healthy volunteers as determined by Cmax, AUC (0-24 hours), reported AE, vital signs, safety laboratory tests, ECG and physical examinations<br><br>Part 2:<br>the effect of supra-therapeutic dose of garenoxacin following 5 days of treatment on QT intervals, corrected with Fredericia's method (QTcf), as measured by the largest upper bound of 95% one-sided confidence intervals for the eight mean changes in QTcf from time-matched baseline ECG recordings, compared to placebo