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
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started Jan 2011
Shorter than P25 for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 28, 2011
June 1, 2011
3 months
December 17, 2010
June 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 (3)
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)
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Researche Site
London, UK, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2010
First Posted
December 23, 2010
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 28, 2011
Record last verified: 2011-06