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

NCT ID: NCT01016951

Last Updated: 2010-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-06-30

Brief Summary

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.

Conditions

Healthy; COPD

Keywords

Phase I; Safety study; AZD9164

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

A

AZD9164

Group Type: EXPERIMENTAL

AZD9164 Turbuhaler®

Intervention Type: DRUG

Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits.

The COPD patients will receive a dose of 1000 µg.

B

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Turbuhaler®

Intervention Type: DRUG

Dry powder for inhalation via Turbuhaler, MAD

Interventions

AZD9164 Turbuhaler®

Dry powder for inhalation via Turbuhaler, MAD. Starting dose in healthy volunteers is 400 µg with up to two dose escalations not exceeding AstraZeneca pre-defined exposure limits.

The COPD patients will receive a dose of 1000 µg.

Intervention Type: DRUG

Placebo Turbuhaler®

Dry powder for inhalation via Turbuhaler, MAD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca

Principal Investigators

Carin Jorup

Role: STUDY_DIRECTOR

AstraZeneca R&D, Lund, Sweden

Aslak Rautio

Role: PRINCIPAL_INVESTIGATOR

Quintiles Hermelinen AB

Locations

Research Site

Linköping, , Sweden

Research Site

Luleå, , Sweden

Countries

Sweden

References

Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52.

Reference Type: DERIVED

PMID: 24669829 (View on PubMed)

Other Identifiers

EudraCT number: 2009-015645-23

Identifier Type: -

Identifier Source: secondary_id

D1882C00002

Identifier Type: -

Identifier Source: org_study_id