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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01016951 |
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Date of registration:
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19/11/2009 |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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) |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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36 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01016951 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Carin Jorup |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca R&D, Lund, Sweden |
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Name:
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Aslak Rautio |
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Address:
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Telephone:
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Email:
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Affiliation:
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Quintiles Hermelinen AB |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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COPD
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Healthy
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Intervention(s)
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Drug: AZD9164 Turbuhaler®
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Drug: Placebo Turbuhaler®
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Investigation of PD effects
[Time Frame: Spirometry at screening and during the residential stay]
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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]
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Secondary ID(s)
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D1882C00002
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EudraCT number: 2009-015645-23
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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