Pharmacokinetic and Pharmacoscintigraphic Comparison of T... | NCT02207426

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

NCT02207426

Sponsor

Pharmaero ApS

Status

Completed

Last Update Posted

Apr 10, 2017Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Tobramycin

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-005288-19	EudraCT Number

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.

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Aug 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Aug 1, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2017

Last Update Posted Date

Apr 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TobrAir® 6.0	Experimental	Tobramycin 75mg inhalation solution	Drug: Tobramycin
TOBI® / PARI LC® PLUS Nebulizer	Experimental	Tobramycin 300mg nebulizer solution	Drug: Tobramycin
TOBI® Podhaler™	Experimental	Tobramycin 112mg (4x28mg) inhalation powder	Drug: Tobramycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tobramycin	Drug		TOBI® / PARI LC® PLUS Nebulizer TOBI® Podhaler™ TobrAir® 6.0

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bioavailability of tobramycin	Bioavailability of tobramycin	3 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Nov 8, 2022
Reset	Sep 14, 2023

ID	Term
D009328	Nebramycin
D007612	Kanamycin
D000617	Aminoglycosides
D006027	Glycosides
D002241