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OpenTrials
Completed

NCT Number: NCT00686179

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

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.

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Key information

Conditions

Healthy

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

AZD3480

Drug

Capsule, oral, single dose, 6 days

Other names: TC-1734-226

moxifloxacin

Drug

Capsule(encapsulated), oral, single dose

Placebo

Drug

Capsule, oral, single dose

Primary outcomes

  1. 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

    Time frame: 11 dECG measurements x 4 (4-way crossover)

Secondary outcomes

  1. QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals

    Time frame: 11 dECG measurements x 4 (4-way crossover)

  2. Plasma concentration (AUC, Cmax, tmax etc)

    Time frame: 11 PK-measurements x 4 (4-way crossover)

  3. Registration of AEs, blood pressure, ECG, clinical laboratory tests

    Time frame: From enrolment to follow-up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Acronym: TQT

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 29, 2008
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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