To Investigate the Effects of AZD1981 on the QT Interval

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: AZD1981, 2000mg; Drug: AZD1981, 200mg; Drug: Moxifloxacin, 400mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom
      • Researche Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD1981, 2000mg; Single oral dose, tablets
Experimental: 2	Drug: AZD1981, 200mg; Single oral dose, tablets
Experimental: 3	Drug: Moxifloxacin, 400mg; Single oral dose, capsule
Placebo Comparator: 4	Drug: Placebo; Single oral dose, tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF	dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF	dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS.	dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG.	Adverse events recorded at all four residential visits (one week washout between visits) and at follow up (7-10 days following last residential visit)

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: D9830C00011; 2010-023338-22