AZD9164 Single Ascending Dose Study in Healthy Male Subjects
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00847249
First received: February 12, 2009
Last updated: September 22, 2009
Last verified: September 2009
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Purpose
The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: AZD9164 Drug: Placebo |
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, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Single Ascending Doses in Healthy Male Subjects |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: up to 48 hours post-dose. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: up to 48 hours post-dose. ] [ Designated as safety issue: No ]
- Local and extrapulmonary effects [ Time Frame: up to 48 hours post-dose. ] [ Designated as safety issue: No ]
Enrollment: | 65 |
Study Start Date: | February 2009 |
Study Completion Date: | April 2009 |
Arms | Assigned Interventions |
---|---|
Experimental: 1
Solution for nebulisation, inhaled
|
Drug: AZD9164
Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
|
Placebo Comparator: 2
Solution for nebulisation, inhaled
|
Drug: Placebo
Each subject will receive a single-dose.
|
Eligibility
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start
Exclusion Criteria:
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examinations
- Use of any prescribed or non-prescribed medication
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847249
Locations
Sweden | |
Research Site | |
Lund, Sweden |
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: | Anders Luts | AstraZeneca |
Principal Investigator: | Ulf Malmqvist | Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden |
More Information
No publications provided
Keywords provided by AstraZeneca:
ClinicalTrials.gov processed this record on September 26, 2012
No publications provided
Responsible Party: | Anders Luts, Medical Science Director, Emerging Project, Team 3, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00847249 History of Changes |
Other Study ID Numbers: | D1882C00001, EudraCT No.2008-007188-18 |
Study First Received: | February 12, 2009 |
Last Updated: | September 22, 2009 |
Health Authority: | Sweden: Medical Products Agency |
Keywords provided by AstraZeneca:
safety tolerability healthy inhalation Healthy males |
ClinicalTrials.gov processed this record on September 26, 2012