Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers

A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00809289

Acronym

TQT

Enrollment

Registered

2008-12-17

Start date

2008-12-31

Completion date

2009-07-31

Last updated

2011-04-07

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

Conditions

Fibromyalgia

Keywords

Thorough QT/QTc study

Brief summary

This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.

Interventions

DRUGesreboxetine

Once daily administration of 4mg esreboxetine for 3 days, followed by 8mg esreboxetine for 3 days, followed by 10mg esreboxetine for 3 days. Drug will be administered double-blind.

DRUGplacebo

Once daily administration of placebo for 9 days. Placebo will be administered double blind

DRUGmoxifloxacin

Once daily administration of placebo for 8 days followed by open label single oral dose of 400mg moxifloxacin on day 9

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects aged 18 to 55 years * Body mass Index of approximately 18 to 30kg/m2 * Informed consent document signed by the subject or a legally acceptable representative * Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion criteria

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening * Conditions possibly affecting drug absorption * 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen * Positive urine drug screen * Hypersensitivity to moxifloxacin * Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication

Design outcomes

Primary

Measure	Time frame
To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers	Up to 24 hours

Secondary

Measure	Time frame
To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval	Up to 24 hours
To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers	Up to 24 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026