AZD2115 Single Ascending Dose Study

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Lung Disease Causing Persistent Narrowing of the Airways
• Interventions: Drug: AZD2115; Drug: Placebo

• Registration Number: NCT01283984
• Lead Sponsor: AstraZeneca

Brief Summary

AZD2115 Single Ascending Dose Study

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2115	AZD2115
2	Placebo	Placebo to AZD2115

Primary Outcome Measures

Name	Time	Method
To evaluate the frequency of adverse events of inhaled single doses of AZD2115	Measurements will be taken at follow up 7-13 days post dose.
To evaluate the laboratory safety assessments of inhaled single doses of AZD2115	Measurements will be taken at follow up 7-13 days post dose.
To evaluate the vital signs of inhaled single doses of AZD2115	Measurements will be taken at follow up 7-13 days post dose.
To evaluate the physical examination of inhaled single doses of AZD2115	Measurements will be taken at follow up 7-13 days post dose.
To evaluate the ECG of inhaled single doses of AZD2115	Measurements will be taken at follow up 7-13 days post dose.

Secondary Outcome Measures

Name	Time	Method
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).	Frequent sampling occasions during study days, before and up to 48 h after dosing
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - FEV1	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.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - potassium	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.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - glucose	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.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - systolic and diastolic blood pressure	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.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - pulse, heart rate	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.
To investigate the pharmacodynamic effects of inhaled single ascending doses of AZD2115 - QTcF	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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, UK, United Kingdom