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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01222442
Other study ID # D0570C00004
Secondary ID
Status Completed
Phase Phase 1
First received October 12, 2010
Last updated February 15, 2011
Start date November 2010
Est. completion date February 2011

Study information

Verified date February 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate the effect of AZD3199 on the electrical activity of the heart. The effect of AZD3199 will be compared to a licensed antibiotic (moxifloxacin). Moxifloxacin effects on the electrical activity of the heart are well known. Safety and tolerability of AZD3199 and how much AZD3199 enters the blood circulation will also be assessed.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy male subjects aged 18 to 45 years (inclusive)

- Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 60 and 100 kg.

- Be a non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.

- Be able to inhale from the Turbuhaler inhaler according to given instructions.

Exclusion Criteria:

- Any clinically significant disease or disorder

- Any clinically relevant abnormal findings at screening examination

- History of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalaemia, or family history of long QT syndrome).

- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD3199
Single dose, oral inhalation
Moxifloxacin
Single dose, oral encapsulated tablet
Other:
Placebo comparator
Single dose, oral inhalation

Locations

Country Name City State
United Kingdom Research Site London UK

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the effect of AZD3199 on the QT interval QTcF or QTcI (algorithm based decision) Throughout the study Yes
Secondary To investigate the effect of AZD3199 on additional electrocardiogram variables QTcF or QTcI dependent on variable confirmed as primary
Holter-Bin QT
Throughout the study Yes
Secondary To assess the pharmacokinetics of single doses of AZD3199. AUC(0-24)
Cmax
tmax
Throughout the study No
Secondary To evaluate the safety and tolerability of single doses of AZD3199. Adverse events - type of events and number of subjects experiencing adverse events.
Laboratory safety assessments, pulse, blood pressure and electrocardiogram interpretation - Summarised using descriptive stats. Judged regarding high/low values or changes from pre-dose.
Throughout the study Yes
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