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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006168-46-NL

Enrollment

Registered

2006-12-22

Start date

2006-12-21

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indication: bacterial infections MedDRA version: 8.1 Level: HLT Classification code 10004047 Term: Bacterial infections NEC

Interventions

Product Name: Garenoxacin Product Code: SCH 575737 Pharmaceutical Form: Powder for oral suspension Pharmaceutical form of the placebo: Powder and solvent for oral suspension Route of administration of

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: 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 Part 2: 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	—

Measure

Time frame

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: 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 Part 2: 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

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026