Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tobramycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TobrAir® 6.0<br>Tobramycin 75mg inhalation solution | Drug: Tobramycin<br> <br> |
| Experimental: TOBI® / PARI LC® PLUS Nebulizer<br>Tobramycin 300mg nebulizer solution | Drug: Tobramycin<br> <br> |
| Experimental: TOBI® Podhaler™<br>Tobramycin 112mg (4x28mg) inhalation powder | Drug: Tobramycin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of tobramycin | Bioavailability of tobramycin | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scintigraphic measurement of lung deposition of radiolabelled tobramycin | Scintigraphic measurement of lung deposition of radiolabelled tobramycin | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers