Clinical trial NCT01265641: To Investigate the Effects of AZD1981 on the QT Interval
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-23
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF
timeFrame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
Secondary outcomes:
measure: To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF
timeFrame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
measure: To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS.
timeFrame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose
measure: To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG.
timeFrame: Adverse events recorded at all four residential visits (one week washout between visits) and at follow up (7-10 days following last residential visit)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Researche Site
state: UK
Study officials:
References: