To Investigate the Effects of AZD1981 on the QT Interval

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265641
• Other study ID #: D9830C00011
• Secondary ID: 2010-023338-22
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2010
• Last updated: June 27, 2011
• Start date: January 2011
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AZD1981, 2000mg
Single oral dose, tablets
• AZD1981, 200mg
Single oral dose, tablets
• Moxifloxacin, 400mg
Single oral dose, capsule
• Placebo
Single oral dose, tablets

Locations

Country	Name	City	State
United Kingdom	Researche Site	London	UK

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes