NCT02207426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

August 1, 2014

Last Update Submit

April 7, 2017

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of tobramycin

    Bioavailability of tobramycin

    3 days

Secondary Outcomes (1)

  • Scintigraphic measurement of lung deposition of radiolabelled tobramycin

    1 day

Study Arms (3)

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

TobramycinDRUG
TOBI® / PARI LC® PLUS NebulizerTOBI® Podhaler™TobrAir® 6.0

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Tobramycin

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Pharmaero ApS Pharmaero ApS

    Pharmaero ApS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 4, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

GB(1)