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To Investigate the Effects of AZD1981 on the QT Interval

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: December 17, 2010
Last updated: June 27, 2011
Last verified: June 2011
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 Intervention Phase
Drug: AZD1981, 2000mg
Drug: AZD1981, 200mg
Drug: Moxifloxacin, 400mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]
  • 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) ]

Estimated Enrollment: 44
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01265641

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

Responsible Party: Christer Hultquist / MSD, AstraZeneca Identifier: NCT01265641     History of Changes
Other Study ID Numbers: D9830C00011
Study First Received: December 17, 2010
Last Updated: June 27, 2011

Additional relevant MeSH terms:
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 processed this record on May 24, 2017