This trial is active, not recruiting.

Condition healthy
Treatment tobramycin
Phase phase 1
Sponsor Pharmaero ApS
Start date July 2014
End date August 2014
Trial size 12 participants
Trial identifier NCT02207426, 2013-005288-19, TobrAir - CT0040


This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Tobramycin 75mg inhalation solution
Tobramycin 300mg nebulizer solution
Tobramycin 112mg (4x28mg) inhalation powder

Primary Outcomes

Bioavailability of tobramycin
time frame: 3 days

Secondary Outcomes

Scintigraphic measurement of lung deposition of radiolabelled tobramycin
time frame: 1 day

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Healthy males or non-pregnant, non-lactating healthy females - Aged 18 to 65 years - Body mass index of 18.0 to 29.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator - Must provide written informed consent - Must agree to use an adequate method of contraception Exclusion Criteria: - Participation in a clinical research study within the previous 3 months - Subjects who have previously been enrolled in this study - Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission and be using an appropriate method of contraception) - Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study - History of chronic respiratory disorders (including asthma) as judged by the investigator

Additional Information

Official title A Phase 1 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.
Description This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each subject receives tobramycin with 3 different inhalation devices: - 75 mg tobramycin delivered to the airways via TobrAir® 6.0. - 300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy® SX. - 112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI® Podhaler™. Each dose is separated by a minimum washout of at least 68 h. Blood samples for PK analysis of tobramycin will be collected at regular time intervals until 24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo scintigraphic assessments.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pharmaero ApS.