To Investigate the Effects of AZD1981 on the QT Interval

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01265641
First received: December 17, 2010
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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
Asthma
Drug: AZD1981, 2000mg
Drug: AZD1981, 200mg
Drug: Moxifloxacin, 400mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265641

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

No publications provided

Responsible Party: Christer Hultquist / MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01265641     History of Changes
Other Study ID Numbers: D9830C00011, 2010-023338-22
Study First Received: December 17, 2010
Last Updated: June 27, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014