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Completed

NCT Number: NCT01265641

To Investigate the Effects of AZD1981 on the QT Interval

The purpose of this research study is to evaluate the effect of AZD1981 on the electrical activity of the heart, in particular when the heart muscle is relaxed during a heart beat cycle. The effect of AZD1981 will be compared to a licensed antibiotic (moxifloxacin) which is well known to affect the electrical activity of the heart, but this effect is known to be at levels that are safe at the dose used in this study. The investigators will also compare the effects of AZD1981 with a "dummy drug" (placebo). The investigators will also be evaluating how safe and well tolerated AZD1981 is and how much AZD1981 enters the blood circulation by collecting blood during the study.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Researche Site

London, UK, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers aged 18 to 55 years (inclusive)
  • Subjects must be willing to use barrier methods of contraception during study and for 3 months after last dosing.
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months

Exclusion criteria

  • Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
  • History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia, personal or family history of arrhythmia or long QT syndrome)

Treatment and study plan

AZD1981, 2000mg

Drug

Single oral dose, tablets

AZD1981, 200mg

Drug

Single oral dose, tablets

Moxifloxacin, 400mg

Drug

Single oral dose, capsule

Placebo

Drug

Single oral dose, tablets

Primary outcomes

  1. To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF

    Time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose

Secondary outcomes

  1. To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF

    Time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose

  2. To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS.

    Time frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose

  3. To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG.

    Time frame: Adverse events recorded at all four residential visits (one week washout between visits) and at follow up (7-10 days following last residential visit)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four-period Crossover Study in Healthy Male Volunteers, to Assess the Effect on QT/QTc Interval of Single Oral Doses of AZD1981 (200 mg and 2000 mg) Using Moxifloxacin (Avelox®) as a Positive Control

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 23, 2010
Registry last updated
Jun 28, 2011

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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