AZD2115 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01283984
First received: January 5, 2011
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

AZD2115 Single Ascending Dose Study


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Lung Disease Causing Persistent Narrowing of the Airways
Drug: AZD2115
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the frequency of adverse events of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at screening ] [ Designated as safety issue: Yes ]
  • To evaluate the laboratory safety assessments of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at screening ] [ Designated as safety issue: Yes ]
  • To evaluate the vital signs of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at screening ] [ Designated as safety issue: Yes ]
  • To evaluate the physical examination of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at screening ] [ Designated as safety issue: Yes ]
  • To evaluate the ECG of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at screening ] [ Designated as safety issue: Yes ]
  • To evaluate the frequency of adverse events of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken pre-dose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • To evaluate the laboratory safety assessments of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at pre-dose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • To evaluate the vital signs of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at pre-dose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • To evaluate the physical examination of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at pre-dose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • To evaluate the ECG of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at pre-dose ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the ECG of inhaled single doses of AZD2115 [ Time Frame: Measurements will be taken at follow up 7-13 days post dose. ] [ Designated as safety issue: Yes ]

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). [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD2115
Drug: AZD2115
Single dose, oral inhalation (nebuliser solution)
Placebo Comparator: 2
Placebo to AZD2115
Drug: Placebo
Single dose, oral inhalation (nebuliser solution)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283984

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

No publications provided

Responsible Party: Carin Jorup / Medical Science Director, AstraZeneca R&D Lund
ClinicalTrials.gov Identifier: NCT01283984     History of Changes
Other Study ID Numbers: D3060C00001
Study First Received: January 5, 2011
Last Updated: August 17, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
inhaled
respiratory disease

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014