Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days

A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00686179

Acronym

TQT

Enrollment

Registered

2008-05-29

Start date

2008-01-31

Completion date

2008-08-31

Last updated

2008-09-25

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

Conditions

Healthy

Keywords

TQT, ECG, QT, QTc, AZD3480, ECG(QTc effects)

Brief summary

The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.

Interventions

DRUGAZD3480

Capsule, oral, single dose, 6 days

DRUGMoxifloxacin

Capsule(encapsulated), oral, single dose

DRUGPLACEBO

Capsule, oral, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme) * Physically and mentally healthy male volunteers

Exclusion criteria

* History of clinically significant diseases or illness. * Participation in another study the last 3 months * Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)

Design outcomes

Primary

Measure	Time frame
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3	11 dECG measurements x 4 (4-way crossover)

Secondary

Measure	Time frame
QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals	11 dECG measurements x 4 (4-way crossover)
Plasma concentration (AUC, Cmax, tmax etc)	11 PK-measurements x 4 (4-way crossover)
Registration of AEs, blood pressure, ECG, clinical laboratory tests	From enrolment to follow-up

Outcome results

None listed

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