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

September 24, 2008 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Escalating doses of AZD3480 during 6 days
Drug: AZD3480
Capsule, oral, single dose, 6 days
Other Names:
  • TC-1734-226
Experimental: 2
Repeated doses of AZD3480 during 6 days
Drug: AZD3480
Capsule, oral, single dose, 6 days
Other Names:
  • TC-1734-226
Placebo Comparator: 3
Placebo during 6 days
Drug: PLACEBO
Capsule, oral, single dose
Active Comparator: 4
Placebo during 5 days, active day 6
Drug: Moxifloxacin
Capsule(encapsulated), oral, single dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Hans-Göran Hårdemark, Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 24, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3690C00004
  • EUdract NO 2007-004859-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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