Delivery of Tobramycin in Healthy Volunteers (QBR115800)
Research type
Research Study
Full title
A Phase I Study in Healthy Volunteers Investigating the Delivery of Tobramycin Using the TobrAir® 6.0 Device Compared with the Delivery of Marketed Tobramycin Nebuliser Solution (TOBI®) by PARI LC® PLUS and PARI TurboBoy® SX and with Delivery of Tobramycin by the TOBI® Podhaler™ Device, Using Pharmacokinetic and Pharmacoscintigraphic Methods
IRAS ID
145388
Contact name
Mari Evans
Contact email
N/A
Sponsor organisation
Pharmaero ApS
Eudract number
2013-005288-19
Clinicaltrials.gov Identifier
Research summary
The study drug and device (TobrAir®) is being developed by the Sponsor company Pharmaero ApS, to provide an improved inhalation treatment of long term bacterial infection in patients with cystic fibrosis.
The main aim of this study is to characterise the pharmacokinetic profile (how the study drug is taken up by the body) of tobramycin from the TobrAir 6.0 device with a view to obtaining a similar profile to that achieved using the PARI LC® PLUS nebuliser and the TOBI® Podhaler™.
Approximately 12 healthy subjects will be administered the following regimens, separated by a minimum washout period of at least 68 h:
Regimen A: A metered dose of 75 mg tobramycin delivered to the airways via the TobrAir® 6.0 device in accordance with study specific instructions
Regimen B: A metered (fill) dose of 300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy® SX nebuliser compressor combination using tidal breathing to dryness, in accordance with patient instructions
Regimen C: A single dose of 112 mg tobramycin (4 x 28 mg TOBI® Podhaler™ dry powder capsules) delivered via the TOBI® Podhaler™ device in accordance with patient instructions.
For Regimens A and B, the tobramycin solution will be radiolabelled with technetium-99m.
REC name
Wales REC 1
REC reference
14/WA/0181
Date of REC Opinion
12 Jun 2014
REC opinion
Further Information Favourable Opinion