To Investigate the Effects of AZD1981 on the QT Interval

NCT01265641 — Phase 1, Completed, 44 participants, AstraZeneca

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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

Registry	NCT01265641
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: quadruple, basic science
Enrollment	44 (Estimated)
Sponsor	AstraZeneca (Industry)
Conditions	Asthma
Interventions	AZD1981, 2000mg, AZD1981, 200mg, Moxifloxacin, 400mg, Placebo (Drug)
Dates	start 2011-01-01, primary completion 2011-04-01, completion 2011-04-01, first posted 2010-12-23, last updated 2011-06-28
Locations	1 site in United Kingdom

-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.

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+Arms and interventions

Arm	Type	Interventions
1	Experimental	Drug: AZD1981, 2000mg
2	Experimental	Drug: AZD1981, 200mg
3	Experimental	Drug: Moxifloxacin, 400mg
4	Placebo comparator	Drug: Placebo

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

+Outcome measures

Primary outcomes

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 outcomes

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)]

+Eligibility

Sex: Male, ages: 18 Years to 55 Years, accepts healthy volunteers

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)

+Locations (1)

Facility	City	Country	Status
Researche Site	London, UK	United Kingdom