A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects
This is a single centre, single dose pharmacokinetic/safety study in male and female asthmatic subjects. Subjects will receive a single dose of 10 mg of AER 001 administered as a dry powder using a handheld device. The goals of this study are to understand the pharmacokinetics and safety of AER 001 administered as a dry powder in mild to moderate asthmatics.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||February 2008|
Drug: AER 001
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|