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
  Purpose

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.


Condition Intervention Phase
Healthy
COPD
Drug: AZD9164 Turbuhaler®
Drug: Placebo Turbuhaler®
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
AZD9164
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.

Placebo Comparator: B
Placebo
Drug: Placebo Turbuhaler®
Dry powder for inhalation via Turbuhaler, MAD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016951

Locations
Sweden
Research Site
Linkoping, Sweden
Research Site
Luleå, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carin Jorup AstraZeneca R&D, Lund, Sweden
Principal Investigator: Aslak Rautio Quintiles Hermelinen AB
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carin Jorup MD, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01016951     History of Changes
Other Study ID Numbers: D1882C00002, EudraCT number: 2009-015645-23
Study First Received: November 19, 2009
Last Updated: November 18, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Phase I
Safety study
AZD9164

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014