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To Investigate the Effects of AZD1981 on the QT Interval

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ClinicalTrials.gov Identifier: NCT01265641
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: AZD1981, 2000mg Drug: AZD1981, 200mg Drug: Moxifloxacin, 400mg Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : January 2011
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: AZD1981, 2000mg
Single oral dose, tablets
Experimental: 2 Drug: AZD1981, 200mg
Single oral dose, tablets
Experimental: 3 Drug: Moxifloxacin, 400mg
Single oral dose, capsule
Placebo Comparator: 4 Drug: Placebo
Single oral dose, tablets


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the effect of a single supra maximal therapeutic dose of AZD1981on QT interval - QTcF [ Time Frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose ]

Secondary Outcome Measures :
  1. To evaluate the effect of a therapeutic dose of AZD1981on QT interval -QTcF [ Time Frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose ]
  2. To evaluate the effect of AZD1981 on additional electrocardiogram variables - QTcB -RR PR QRS. [ Time Frame: dECG and telemetry measurements taken pre-dose and up to and including 48 hours post dose ]
  3. To evaluate the safety and tolerability of single doses of AZD1981 -frequency of adverse events - laboratory safety assessments - vital signs - physical examination - ECG. [ Time Frame: 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 Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265641


Locations
United Kingdom
Researche Site
London, UK, United Kingdom
Sponsors and Collaborators
AstraZeneca
More Information

Responsible Party: Christer Hultquist / MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01265641     History of Changes
Other Study ID Numbers: D9830C00011
2010-023338-22
First Posted: December 23, 2010    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs