AZD2115 Single Ascending Dose Study

NCT01283984 | Completed Phase 1

• 1 other identifier: D3060C00001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

AZD2115 Single Ascending Dose Study

Conditions

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

Keywords

Safety; tolerability; healthy; inhaled; respiratory disease

Outcome Measures

Primary Outcomes (20)

• To evaluate the frequency of adverse events of inhaled single doses of AZD2115

  Measurements will be taken at screening

• To evaluate the laboratory safety assessments of inhaled single doses of AZD2115

  Measurements will be taken at screening

• To evaluate the vital signs of inhaled single doses of AZD2115

  Measurements will be taken at screening

• To evaluate the physical examination of inhaled single doses of AZD2115

  Measurements will be taken at screening

• To evaluate the ECG of inhaled single doses of AZD2115

  Measurements will be taken at screening

• To evaluate the frequency of adverse events of inhaled single doses of AZD2115

  Measurements will be taken pre-dose

• 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

• 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 pre-dose

• 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

• 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 pre-dose

• 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

• 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 pre-dose

• 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

• 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 pre-dose

• 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

• To evaluate the ECG of inhaled single doses of AZD2115

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

Secondary Outcomes (7)

• 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.

Study Arms (2)

1

EXPERIMENTAL

AZD2115

Drug: AZD2115

2

PLACEBO COMPARATOR

Placebo to AZD2115

Drug: Placebo

Interventions

AZD2115 DRUG

Single dose, oral inhalation (nebuliser solution)

1

Placebo DRUG

Single dose, oral inhalation (nebuliser solution)

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, UK, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Respiration Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 26, 2011
• Study Start: January 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 18, 2011

Record last verified: 2011-08

Locations

GB (1)