A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects
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|ClinicalTrials.gov Identifier: NCT00785668|
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : November 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: AER 001||Phase 1|
- Single centre, single dose PK/safety study in male and female asthmatic subjects.
- Approximately 10 subjects will be dosed.
- Treatments will be administered by dry powder inhalation using a handheld device
- Subjects will attend the Unit for screening and if eligible return to the Unit on the day of dosing (Day 1). Subjects will be required to stay overnight in the Unit and will be discharged on Day 2.
- On study Day 1, subjects are to receive a single administration of AER 001. N.B. Screening will take place within 28 days prior to administration of AER 001.
Primary objective: To investigate the pharmacokinetics of AER 001 administered as a dry powder in mild to moderate asthmatics.
Secondary objective: To investigate the safety of AER 001 administered as a dry powder in mild to moderate asthmatics.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects|
|Study Start Date :||November 2007|
|Actual Study Completion Date :||February 2008|
Drug: AER 001
- The area under the plasma concentration-time curves will be the primary PK parameter. Maximum observed plasma drug concentrations, time of occurrence of Cmax, the apparent terminal rate constant and corresponding half-life will also be derived. [ Time Frame: 24 hours ]
- Safety evaluation will include lung function measurements, blood pressure, heart rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, urinalysis, urine and urine microscopy, if required) and adverse events. [ Time Frame: 24 hours ]
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): NCT00785668
|Guy's Drug Research Unit a division of Quintiles Ltd.|
|London, England, United Kingdom, SE1 1YR|
|Principal Investigator:||Darren Wilbraham, MBBS, DCPSA||Guy's Drug Research Unit a division of Quintiles Ltd.|