Completed

An Open Label, Part-randomised, Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate (FF) When Administered as FF Inhalation Powder From the Novel Dry Powder Inhaler in Healthy Subjects

What is being tested

FF, 50 mcg

+ FF, 100 mcg

+ FF, 200 mcg

Drug

Who is being recruted

Bronchial Diseases+6

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 18 to 65 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: August 2012

See protocol details

Summary

Principal SponsorGlaxoSmithKline

Last updated: June 12, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to demonstrate dose proportionality of the FF (50 microgram (mcg), 100 mcg or 200 mcg), when administered as a single and repeat dose from the NDPI containing FF formulated with lactose. In addition, the aim of this study is to determine the absolute bioavailability of the FF single strip product using the high strength product administered as a single dose with multiple inhalations and using 250 mcg intravenous (IV) FF. This is a, part-randomized, open-label, 4 way crossover study (4 periods) in healthy adult subjects. During each period, subjects will receive FF in the morning and serial pharmacokinetic (PK) sampling (for up to 10 days for the inhaled treatment and up to 3 days for the IV treatment) and safety assessments will be performed. Each period will be separated by a washout period of at least 7 days and a follow-up telephone call will occur 7 -14 days after the last dose of study drug. The total duration of the study will be approximately 13-14 weeks for each subject.

NCT01669070

Principal SponsorGlaxoSmithKline

Last updated: June 12, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract DiseasesAsthma

Criteria

7 inclusion criteria required to participate

Able to satisfactorily use the NDPI

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and bilirubin < or =1.5x upper limit of normal (ULN)

Average QT duration corrected for heart rate by Fridericia's formula (QTcF) < 450 millisecond

Current non-smokers

Show More Criteria

17 exclusion criteria prevent from participating

Abuse of alcohol

Current or chronic history of liver disease, or known hepatic or biliary abnormalities

Donation of more than 500 mL blood within a 56 day period

Exposure to more than four new chemical entities within 12 months prior to the first dosing day

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Each subject will receive a single dose of 300 mcg FF (6 inhalations of 50 mcg FF) on Day 1 of the respective period per randomization sequence, followed by 50 mcg FF once daily for 7 days, on Days 3-9 inclusive, administered from the NDPI.

Group II

Experimental

Each subject will receive a single dose of 600 mcg FF (6 inhalations of 100 mcg FF) on Day 1 of the respective period per randomization sequence, followed by 100 mcg FF once daily for 7 days, on Days 3-9 inclusive, administered from the NDPI.

Group III

Experimental

Each subject will receive a single dose of 1200 mcg FF (6 inhalations of 200 mcg FF) on Day 1 of the respective period per randomization sequence, followed by 200 mcg FF once daily for 7 days, on Days 3-9 inclusive, administered from the NDPI.

Group IV

Experimental

Each subject will receive a single dose of 250 mcg FF, administered as an IV infusion over 20 minutes on Day 1 of the respective period per randomization sequence.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

GSK Investigational Site

Groningen, NetherlandsOpen GSK Investigational Site in Google Maps

CompletedOne Study Center