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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01265641
Enrollment
44
Registered
2010-12-23
Start date
2011-01-31
Completion date
2011-04-30
Last updated
2011-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGAZD1981, 2000mg

Single oral dose, tablets

DRUGAZD1981, 200mg

Single oral dose, tablets

DRUGMoxifloxacin, 400mg

Single oral dose, capsule

DRUGPlacebo

Single oral dose, tablets

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcFdECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose

Secondary

MeasureTime frame
To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcFdECG 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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026