Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

Randomized, 4-Way, Crossover Single Dose, Placebo And Active Controlled Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01287793

Enrollment

Registered

2011-02-01

Start date

2011-01-31

Completion date

2011-05-31

Last updated

2011-05-24

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

Conditions

Healthy

Brief summary

Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.

Detailed description

evaluation of effect of tigecycline on QT/QTc in healthy volunteers

Interventions

DRUGtigecycline

intravenous, 200 mg, single dose

DRUGmoxifloxacin

oral tablet, 400 mg, single dose

DRUG100 mL 0.9% Sodium Chloride intravenous

intravenous fluid, 100 mL, single dose

DRUGplacebo

0.9% Sodium Chloride intravenous 100mL, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy * Body mass index 17.5 - 30.5 kg * Total body weight greater than 50 kg

Exclusion criteria

* Recent history of diarrhea * Use of oral antibiotics in the last 2 weeks * History of risk factors for QT prolongation pregnant females * Nursing females

Design outcomes

Primary

Measure	Time frame
Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses	Up to 96 hours

Secondary

Measure	Time frame
QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods	-2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Maximum concentration pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Time of maximum concentration pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Elimination rate constant pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Clearance pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Response-exposure relationships between QT/QTc and tigecycline concentration	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours
Half life pharmacokinetic endpoint for tigecycline	-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026