AZD2115 Single Ascending Dose Study

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283984
• Other study ID #: D3060C00001
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2011
• Last updated: August 17, 2011
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: August 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

AZD2115 Single Ascending Dose Study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2011
• Est. primary completion date: August 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 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

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• AZD2115
Single dose, oral inhalation (nebuliser solution)
• Placebo
Single dose, oral inhalation (nebuliser solution)

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 evaluate the frequency of adverse events of inhaled single doses of AZD2115		Measurements will be taken at screening	Yes
Primary	To evaluate the laboratory safety assessments of inhaled single doses of AZD2115		Measurements will be taken at screening	Yes
Primary	To evaluate the vital signs of inhaled single doses of AZD2115		Measurements will be taken at screening	Yes
Primary	To evaluate the physical examination of inhaled single doses of AZD2115		Measurements will be taken at screening	Yes
Primary	To evaluate the ECG of inhaled single doses of AZD2115		Measurements will be taken at screening	Yes
Primary	To evaluate the frequency of adverse events of inhaled single doses of AZD2115		Measurements will be taken pre-dose	Yes
Primary	To evaluate the frequency of adverse events of inhaled single doses of AZD2115		Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose	Yes
Primary	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.	Yes
Primary	To evaluate the laboratory safety assessments of inhaled single doses of AZD2115		Measurements will be taken at pre-dose	Yes
Primary	To evaluate the laboratory safety assessments of inhaled single doses of AZD2115		Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose	Yes
Primary	To evaluate the laboratory safety assessments of inhaled single doses of AZD2115		Measurements will be taken at follow up 7-13 days post dose.	Yes
Primary	To evaluate the vital signs of inhaled single doses of AZD2115		Measurements will be taken at pre-dose	Yes
Primary	To evaluate the vital signs of inhaled single doses of AZD2115		Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose	Yes
Primary	To evaluate the vital signs of inhaled single doses of AZD2115		Measurements will be taken at follow up 7-13 days post dose.	Yes
Primary	To evaluate the physical examination of inhaled single doses of AZD2115		Measurements will be taken at pre-dose	Yes
Primary	To evaluate the physical examination of inhaled single doses of AZD2115		Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose	Yes
Primary	To evaluate the physical examination of inhaled single doses of AZD2115		Measurements will be taken at follow up 7-13 days post dose.	Yes
Primary	To evaluate the ECG of inhaled single doses of AZD2115		Measurements will be taken at pre-dose	Yes
Primary	To evaluate the ECG of inhaled single doses of AZD2115		Measurements will be taken at multiple timelpoints during dosing day through to 48 hours post-dose	Yes
Primary	To evaluate the ECG of inhaled single doses of AZD2115		Measurements will be taken at follow up 7-13 days post dose.	Yes
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No