To Investigate the Effects of AZD1981 on the QT Interval
Status and phase
Conditions
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
44 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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