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Completed

NCT Number: NCT01283984

AZD2115 Single Ascending Dose Study

AZD2115 Single Ascending Dose Study

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Disease Causing Persistent Narrowing of the Airways Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, UK, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
  • Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the day of dosing until 3 months after dosing with the investigational product.
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be able to inhale from a Spira nebuliser according to given instructions

Exclusion criteria

  • Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
  • Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:
  • PR (PQ) interval prolongation >200 ms (first degree AV block)
  • Intermittent second or third degree AV block (based on screening or pre-dose ECG)
  • Incomplete, full or intermittent bundle branch block (QRS <110 ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
  • Abnormal T wave morphology, particularly in the protocol defined primary lead
  • Dropped beats
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2115 and/or excipients
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Serum potassium concentration of <3.80 mmol/L on admission (Day -1)

Treatment and study plan

AZD2115

Drug

Single dose, oral inhalation (nebuliser solution)

Placebo

Drug

Single dose, oral inhalation (nebuliser solution)

Primary outcomes

  1. To evaluate the frequency of adverse events of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at screening

  2. To evaluate the laboratory safety assessments of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at screening

  3. To evaluate the vital signs of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at screening

  4. To evaluate the physical examination of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at screening

  5. To evaluate the ECG of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at screening

  6. To evaluate the frequency of adverse events of inhaled single doses of AZD2115

    Time frame: Measurements will be taken pre-dose

  7. To evaluate the frequency of adverse events of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose

  8. To evaluate the frequency of adverse events of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at follow up 7-13 days post dose.

  9. To evaluate the laboratory safety assessments of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at pre-dose

  10. To evaluate the laboratory safety assessments of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose

  11. To evaluate the laboratory safety assessments of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at follow up 7-13 days post dose.

  12. To evaluate the vital signs of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at pre-dose

  13. To evaluate the vital signs of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose

  14. To evaluate the vital signs of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at follow up 7-13 days post dose.

  15. To evaluate the physical examination of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at pre-dose

  16. To evaluate the physical examination of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose

  17. To evaluate the physical examination of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at follow up 7-13 days post dose.

  18. To evaluate the ECG of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at pre-dose

  19. To evaluate the ECG of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose

  20. To evaluate the ECG of inhaled single doses of AZD2115

    Time frame: Measurements will be taken at follow up 7-13 days post dose.

Secondary outcomes

  1. To assess the pharmacokinetics of a single dose of AZD2115 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax).

    Time frame: Frequent sampling occasions during study days, before and up to 48 h after dosing

  2. To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1

    Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.

  3. To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium

    Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.

  4. To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose

    Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.

  5. To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure

    Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.

  6. To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate

    Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.

  7. To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF

    Time frame: Measurements will be taken at screening, pre-dose and at multiple timelpoints during dosing day through to 48 hours post-dose and then again at follow up 7-13 days post dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD2115 After Single Ascending Doses in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2011
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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