Pulmonary Disease, Chronic ObstructivePhase 1NCT01691547

A Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol in Healthy Subjects

A Phase 1 study testing UMEC /VI, UMEC and VI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: UMEC /VI, UMEC and VI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 17 Dec 2012to 8 Mar 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy as determined by a responsible and experienced physician, based on a medical evaluation
Male or female between 18 and 65 years of age
Body Mass Index (BMI) within the range 19.0 - 33.0 kilogram (kg)/meters (m)^2 (inclusive)
Average QT interval corrected using Fridericia's (QTcF) formula < 450 millisecond (msec)
Forced Expiratory Volume in 1 second (FEV1) >=80% predicted and a FEV1/Forced Vital Capacity (FVC) ratio >=0.7
Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit

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Alanine transaminase (ALT), alkaline phosphatase and bilirubin <=1.5xupper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
A female subject is eligible to participate if she is confirmed postmenopausal or permanently sterilized; or if she is of child-bearing potential and is abstinent or agrees to use contraception prior to start of dosing until the follow up visit
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Who cannot join

A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
History of respiratory disease (i.e. history of asthmatic symptoms) in the last 10 years.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening or a positive test for human immunodeficiency virus (HIV) antibody.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or a history of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females.
A positive pre-study drug/alcohol screen
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or has had exposure to more than four new chemical entities within 12 months prior to the first dosing day.

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Lactating or pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Glaxo SmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Or the subject is unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice and pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication and for the duration of the study.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Unwillingness or inability to follow the procedures outlined in the protocol
Subject is mentally or legally incapacitated

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Single Dose, Four Way Cross-over Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol Following Single Inhaled Doses of Umeclidinium/Vilanterol Blend + Fluticasone Furoate, Umeclidinium + Vilanterol, Fluticasone Furoate + Vilanterol and Fluticasone Furoate + Umeclidinium in Healthy Subjects

This is a double-blind, single dose (four inhalations), four-way cross over study in healthy subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics (PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two strip configuration. The NDPI will be configured with different combinations of each compound and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device. Study drug will be administered through the inhaled route to healthy subjects in single doses (four inhalations). Each subject will receive treatment in a randomized order Treatment A FF (400 microgram [µg]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100 µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg) over four treatment periods. Each treatment period will be separated by a washout of 7 to 21 days. After the four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication and the maximum duration a subject will be involved in the study is eighteen weeks.

Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the study.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: UMEC /VI, UMEC, VI, FF
Keywords: GW642444 (Vilanterol), pharmacokinetics, pharmacodynamics, GSK573719 (Umeclidinium), healthy subjects, GW685698 (Fluticasone Furoate)
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UMEC /VIDrug
Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2 agonist (LABA). UMEC/VI (blended together) will be available as dry powder in the dose of 125 µg /25 µg per inhalation.
UMECDrug
Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA). UMEC will be available as dry powder in the dose of 125 µg per inhalation.
VIDrug
Vilanterol is a long-acting beta2 agonist (LABA). VI will be available as dry powder in the dose of 25 µg per inhalation.
FFDrug
Fluticasone Furoate is a novel inhaled corticosteroid (ICS). FF will be available as dry powder in the dose of 100 µg per inhalation.

Study groups in NCT01691547
Study group	Role	What they receive
UMEC/VI+FF	Experimental	UMEC (500 µg)/VI(100 µg) (blended together) and FF (400 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. Receives: Drug: UMEC /VI; Drug: FF
UMEC+VI	Experimental	UMEC (500 µg) and VI (100 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. Receives: Drug: UMEC; Drug: VI
FF+VI	Experimental	FF (400 µg) and VI (100 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. Receives: Drug: VI; Drug: FF
FF+UMEC	Experimental	FF (400 µg) and UMEC (500 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. Receives: Drug: UMEC; Drug: FF

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC and Cmax, for each of the treatment groups FF/UMEC/VI, UMEC/VI and FF/VI
The PK parameters and plasma concentrations: area under the concentration time-curve (AUC) from time zero to infinity (AUC(0-inf)) or AUC from time zero to last time of quantifiable concentration AUC(0-t') and maximum observed plasma concentration (Cmax) will be derived for each treatment group following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI and FF/VI using the following treatment ratios: FF:FF/UMEC/VI versus FF/VI, UMEC:FF/UMEC/VI versus UMEC/VI, VI: FF/UMEC/VI versus UMEC/VI and VI: FF/UMEC/VI versus FF/VI.
Measured: 3 days of each treatment period.

Secondary outcomes (7)

AUC(0-inf) or AUC(0-t') and Cmax for FF/UMEC/VI and FF/UMEC
The PK parameters will be derived for FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI and FF/UMEC using the following treatment ratios: UMEC:FF/UMEC/VI versus FF/UMEC and FF:FF/UMEC/VI versus FF/UMEC.
Measured: 3 days of each treatment period in which FF+UMEC/VI or FF+UMEC were administered.
Plasma PK parameters: tmax, AUC(0-t), t (last), t1/2, λz, CL/F and V/F for individual component of each treatment group (FF/UMEC/VI, UMEC/VI, FF/VI and FF/UMEC)
The plasma PK parameters: time to Cmax (tmax), AUC(0-t), time of last measurable concentration (tlast), and terminal phase half-life (t1/2), elimination rate constant (λz), apparent clearance (CL/F) and apparent volume of distribution (V/F) (data permitting) will be derived for FF and UEMC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI, FF/VI and FF/UMEC.
Measured: 3 days of each treatment period.
Urine pharmacokinetic parameters: Ae6, Ae10, Ae14, Ae18. Ae24, Ae36, Fe6, Fe10, Fe14, Fe 18, Fe24 and Fe36; urine t1/2 and CLr for UMEC following each treatment group (FF/UMEC/VI, UMEC/VI, and FF/UMEC)
Urine pharmacokinetic parameters: cumulative amount excreted (Ae) in the time interval Ae6, Ae10, Ae14, Ae18, Ae24, Ae36, percent of dose excreted (þ) in the time interval Fe6, Fe10, Fe14, Fe 18, Fe24 and Fe36; urine half life (urine t1/2) and renal clearance CLr (data permitting) will be assessed for UMEC following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI and FF/UMEC
Measured: Day 1 of each treatment period in which UMEC (single or blended) was administered.
Maximum and weighted mean change from Baseline supine heart rate (0-4 hour (h))
The heart rate of the subjects will be measured following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI, FF/VI and FF/UMEC. Change from Baseline will be calculated as supine heart rate (0-4 h) minus supine heart rate (0-4 h) at Baseline.
Measured: 3 days of each treatment period.
Minimum and weighted mean change from Baseline serum potassium (0-4 h)
The serum potassium of the subjects will be measured following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI, FF/VI and FF/UMEC. Change from Baseline will be calculated as serum potassium (0-4 h) minus serum potassium (0-4 h) at Baseline.
Measured: 3 days of each treatment period.
Maximum and weighted mean change from Baseline serum glucose (0-4 h)
The blood glucose of the subjects will be measured following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI, FF/VI and FF/UMEC. Change from Baseline will be calculated as blood glucose (0-4 h) minus blood glucose (0-4 h) at Baseline.
Measured: 3 days of each treatment period.
Safety and tolerability of FF, UMEC and VI
Safety and tolerability parameters include AEs, ECG, vital signs (pulse rate and systolic and diastolic blood pressure) and laboratory assessments include clinical biochemistry and hematological parameters.
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 20128 Mar 2013

First posted24 Sep 2012 (estimated)
Study start17 Dec 2012
Primary completion8 Mar 2013
Study completion8 Mar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01691547
Sponsor's protocol ID: 116415
Status last verified: Jul 2017
First submitted: 20 Sep 2012
Last updated: 26 Jul 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Single Dose, Four Way Cross-over Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol Following Single Inhaled Doses of Umeclidinium/Vilanterol Blend + Fluticasone Furoate, Umeclidinium + Vilanterol, Fluticasone Furoate + Vilanterol and Fluticasone Furoate + Umeclidinium in Healthy Subjects
ClinicalTrials.gov ID: NCT01691547
Acronym / sponsor ID: 116415
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GW642444 (Vilanterol), pharmacokinetics, pharmacodynamics, GSK573719 (Umeclidinium), healthy subjects, GW685698 (Fluticasone Furoate)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 17 Dec 2012 (actual)
Primary completion: 8 Mar 2013 (actual)
Study completion: 8 Mar 2013 (actual)
First posted: 24 Sep 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
UMEC/VI+FF	Experimental	Drug: UMEC /VI, Drug: FFUMEC (500 µg)/VI(100 µg) (blended together) and FF (400 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study.
UMEC+VI	Experimental	Drug: UMEC, Drug: VIUMEC (500 µg) and VI (100 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study.
FF+VI	Experimental	Drug: VI, Drug: FFFF (400 µg) and VI (100 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study.
FF+UMEC	Experimental	Drug: UMEC, Drug: FFFF (400 µg) and UMEC (500 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Healthy as determined by a responsible and experienced physician, based on a medical evaluation
Male or female between 18 and 65 years of age
Body Mass Index (BMI) within the range 19.0 - 33.0 kilogram (kg)/meters (m)^2 (inclusive)
Average QT interval corrected using Fridericia's (QTcF) formula < 450 millisecond (msec)
Forced Expiratory Volume in 1 second (FEV1) >=80% predicted and a FEV1/Forced Vital Capacity (FVC) ratio >=0.7

Key exclusion criteria (11 listed)

A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
History of respiratory disease (i.e. history of asthmatic symptoms) in the last 10 years.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening or a positive test for human immunodeficiency virus (HIV) antibody.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or a history of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >14 drinks for males or >7 drinks for females.
A positive pre-study drug/alcohol screen

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UMEC /VIUmeclidinium is an inhaled long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2 agonist (LABA). UMEC/VI (blended together) will be available as dry powder in the dose of 125 µg /25 µg per inhalation.	Drug	UMEC/VI+FF
UMECUmeclidinium is an inhaled long-acting muscarinic antagonist (LAMA). UMEC will be available as dry powder in the dose of 125 µg per inhalation.	Drug	FF+UMEC, UMEC+VI
VIVilanterol is a long-acting beta2 agonist (LABA). VI will be available as dry powder in the dose of 25 µg per inhalation.	Drug	FF+VI, UMEC+VI
FFFluticasone Furoate is a novel inhaled corticosteroid (ICS). FF will be available as dry powder in the dose of 100 µg per inhalation.	Drug	FF+UMEC, FF+VI, UMEC/VI+FF

Primary outcome

AUC and Cmax, for each of the treatment groups FF/UMEC/VI, UMEC/VI and FF/VI
Time frame: 3 days of each treatment period.
The PK parameters and plasma concentrations: area under the concentration time-curve (AUC) from time zero to infinity (AUC(0-inf)) or AUC from time zero to last time of quantifiable concentration AUC(0-t') and maximum observed plasma concentration (Cmax) will be derived for each treatment group following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI and FF/VI using the following treatment ratios: FF:FF/UMEC/VI versus FF/VI, UMEC:FF/UMEC/VI versus UMEC/VI, VI: FF/UMEC/VI versus UMEC/VI and VI: FF/UMEC/VI versus FF/VI.

7 secondary outcomes

AUC(0-inf) or AUC(0-t') and Cmax for FF/UMEC/VI and FF/UMEC
Time frame: 3 days of each treatment period in which FF+UMEC/VI or FF+UMEC were administered.
Plasma PK parameters: tmax, AUC(0-t), t (last), t1/2, λz, CL/F and V/F for individual component of each treatment group (FF/UMEC/VI, UMEC/VI, FF/VI and FF/UMEC)
Time frame: 3 days of each treatment period.
Urine pharmacokinetic parameters: Ae6, Ae10, Ae14, Ae18. Ae24, Ae36, Fe6, Fe10, Fe14, Fe 18, Fe24 and Fe36; urine t1/2 and CLr for UMEC following each treatment group (FF/UMEC/VI, UMEC/VI, and FF/UMEC)
Time frame: Day 1 of each treatment period in which UMEC (single or blended) was administered.
Maximum and weighted mean change from Baseline supine heart rate (0-4 hour (h))
Time frame: 3 days of each treatment period.
Minimum and weighted mean change from Baseline serum potassium (0-4 h)
Time frame: 3 days of each treatment period.
Maximum and weighted mean change from Baseline serum glucose (0-4 h)
Time frame: 3 days of each treatment period.
Safety and tolerability of FF, UMEC and VI
Time frame: 18 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
Results for study 116415 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UMEC /VI, UMEC and VI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC and Cmax, for each of the treatment groups FF/UMEC/VI, UMEC/VI and FF/VI (time frame: 3 days of each treatment period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01691547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.