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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207426
• Other study ID #: TobrAir - CT0040
• Secondary ID: 2013-005288-19
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2014
• Last updated: April 7, 2017
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2017
• Source: Pharmaero ApS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tobramycin

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaero ApS

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of tobramycin	Bioavailability of tobramycin	3 days
Secondary	Scintigraphic measurement of lung deposition of radiolabelled tobramycin	Scintigraphic measurement of lung deposition of radiolabelled tobramycin	1 day