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

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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tobramycin

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pharmaero ApS
• Investigators: Study Director: Pharmaero ApS Pharmaero ApS, Pharmaero ApS

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 1, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Tobramycin
• Other Study ID Numbers: TobrAir - CT0040; 2013-005288-19 (EudraCT Number)