A Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Healthy

COPD

Treatments

Drug: Placebo Turbuhaler®

Drug: AZD9164 Turbuhaler®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01016951

EudraCT number: 2009-015645-23

D1882C00002

Details and patient eligibility

About

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled AZD9164 following administration of multiple ascending doses in healthy male and female subjects and COPD patients.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female, age 18-45, COPD patients > 40 years
Healthy subjects and COPD patients; Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy subjects; Females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
COPD patients; Females must have a negative pregnancy test, must not be lactating and must be of non-child-bearing potential, by the following criteria: Post menopausal. Woman below 50 years old will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments, and with LH and FSH levels in the post menopausal range. Women over 50 years of age will be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. - irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
Healthy subjects; Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
COPD patients; Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

Healthy subjects; Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study
COPD patients; Any clinically significant disease or disorder (other than COPD) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study
Healthy subject and COPD patients; Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigator
Healthy subject and COPD patients; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes