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

This study has been terminated.
(Study stopped since it was considered that one of the pre-defined stopping criterion was met.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01016951
First received: November 19, 2009
Last updated: November 18, 2010
Last verified: November 2010

November 19, 2009
November 18, 2010
December 2009
June 2010   (final data collection date for primary outcome measure)
Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01016951 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics samples for AZD9164 [ Time Frame: PK sampling during the residential period and intense PK sampling day 1 and 15 in healthy and day 13 in COPD patients ] [ Designated as safety issue: No ]
  • Investigation of PD effects [ Time Frame: Spirometry at screening and during the residential stay ] [ Designated as safety issue: No ]
  • Pharmacokinetics samples for AZD9164 [ Time Frame: PK sampling during the residential period and intense PK sampling day 1 and day 15 ] [ Designated as safety issue: No ]
  • Investigation of PD effects [ Time Frame: Spirometry at screening and during the residential stay ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
A Phase I, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD9164 Given Once Daily as Inhaled Formulation Via Turbuhaler for 13 Days in Healthy Male and Female Subjects and in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
  • Healthy
  • COPD
  • Drug: 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.

  • Drug: Placebo Turbuhaler®
    Dry powder for inhalation via Turbuhaler, MAD
  • Experimental: A
    AZD9164
    Intervention: Drug: AZD9164 Turbuhaler®
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: Placebo Turbuhaler®
Jorup C, Bengtsson T, Strandgården K, Sjöbring 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01016951
D1882C00002, EudraCT number: 2009-015645-23
No
Carin Jorup MD, Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: Carin Jorup AstraZeneca R&D, Lund, Sweden
Principal Investigator: Aslak Rautio Quintiles Hermelinen AB
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP