AZD8683 Single Ascending Dose Study
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ClinicalTrials.gov Identifier: NCT00979849 |
Recruitment Status
:
Completed
First Posted
: September 18, 2009
Last Update Posted
: March 2, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: AZD8683 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 AZD8683 After Single Ascending Doses in Healthy Male Subjects |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: A
AZD8683
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Drug: AZD8683
Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.
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Placebo Comparator: B
Placebo
|
Drug: Placebo
Solution for nebulisation, inhaled
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- Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing. ]
- Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]
- Pharmacokinetics: Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) and from zero to infinity (AUC), apparent plasma clearance (CL/F) [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]
- Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR). [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]
- Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate. [ Time Frame: Frequent sampling occasions during study days, before and up to 48 h after dosing. ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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 any prescribed or non-prescribed medication

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979849
United States, Pennsylvania | |
Research Site | |
Philadelphia, Pennsylvania, United States |
Study Director: | Gurdrun Schwabe | AstraZeneca R&D Lund | |
Principal Investigator: | Sylvan Hurewitz | AstraZeneca CPU, Philadelphia |
Responsible Party: | AstraZeneca, MSD |
ClinicalTrials.gov Identifier: | NCT00979849 History of Changes |
Other Study ID Numbers: |
D1883C00001 |
First Posted: | September 18, 2009 Key Record Dates |
Last Update Posted: | March 2, 2010 |
Last Verified: | March 2010 |
Keywords provided by AstraZeneca:
safety tolerability healthy inhalation |