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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tobramycin

• Registration Number: NCT02207426
• Lead Sponsor: Pharmaero ApS

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2014-08
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-04
• Study Completion: 2014-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TobrAir® 6.0	Tobramycin	Tobramycin 75mg inhalation solution
TOBI® / PARI LC® PLUS Nebulizer	Tobramycin	Tobramycin 300mg nebulizer solution
TOBI® Podhaler™	Tobramycin	Tobramycin 112mg (4x28mg) inhalation powder

Primary Outcome Measures

Name	Time	Method
Bioavailability of tobramycin	3 days	Bioavailability of tobramycin

Secondary Outcome Measures

Name	Time	Method
Scintigraphic measurement of lung deposition of radiolabelled tobramycin	1 day	Scintigraphic measurement of lung deposition of radiolabelled tobramycin

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom