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AZD2115 Single Ascending Dose Study

Primary Purpose

Chronic Obstructive Pulmonary Disease, Lung Disease Causing Persistent Narrowing of the Airways

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD2115
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring Safety, tolerability, healthy, inhaled, respiratory disease

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

AZD2115

Placebo to AZD2115

Outcomes

Primary Outcome Measures

To evaluate the frequency of adverse events of inhaled single doses of AZD2115
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
To evaluate the vital signs of inhaled single doses of AZD2115
To evaluate the physical examination of inhaled single doses of AZD2115
To evaluate the ECG of inhaled single doses of AZD2115
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
To evaluate the vital signs of inhaled single doses of AZD2115
To evaluate the vital signs of inhaled single doses of AZD2115
To evaluate the vital signs of inhaled single doses of AZD2115
To evaluate the physical examination of inhaled single doses of AZD2115
To evaluate the physical examination of inhaled single doses of AZD2115
To evaluate the physical examination of inhaled single doses of AZD2115
To evaluate the ECG of inhaled single doses of AZD2115
To evaluate the ECG of inhaled single doses of AZD2115
To evaluate the ECG of inhaled single doses of AZD2115

Secondary Outcome Measures

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).
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF

Full Information

First Posted
January 5, 2011
Last Updated
August 17, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01283984
Brief Title
AZD2115 Single Ascending Dose Study
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
AZD2115 Single Ascending Dose Study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Lung Disease Causing Persistent Narrowing of the Airways
Keywords
Safety, tolerability, healthy, inhaled, respiratory disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AZD2115
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo to AZD2115
Intervention Type
Drug
Intervention Name(s)
AZD2115
Intervention Description
Single dose, oral inhalation (nebuliser solution)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose, oral inhalation (nebuliser solution)
Primary Outcome Measure Information:
Title
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at screening
Title
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at screening
Title
To evaluate the vital signs of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at screening
Title
To evaluate the physical examination of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at screening
Title
To evaluate the ECG of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at screening
Title
To evaluate the frequency of adverse events of inhaled single doses of AZD2115
Time Frame
Measurements will be taken pre-dose
Title
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
Title
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.
Title
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at pre-dose
Title
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
Title
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.
Title
To evaluate the vital signs of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at pre-dose
Title
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
Title
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.
Title
To evaluate the physical examination of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at pre-dose
Title
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
Title
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.
Title
To evaluate the ECG of inhaled single doses of AZD2115
Time Frame
Measurements will be taken at pre-dose
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Research Site
City
London
State/Province
UK
Country
United Kingdom

12. IPD Sharing Statement

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AZD2115 Single Ascending Dose Study

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