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Pulmonary Disease, Chronic ObstructivePhase 1NCT01894386

Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses

A Phase 1 study testing FF 400 mcg, UMEC 500 mcg and UMEC 250 mcg 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
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Trial summary

This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram [mcg]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA). Read more about this study

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?
FF 400 mcg, UMEC 500 mcg and UMEC 250 mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
15 Jul 2013to 26 Sep 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

  • Safety
  • Average Corrected QT Interval using Fridericia's formula (QTcF) <450 msec at screening.
  • Forced Expiratory Volume in 1 second (FEV1) >=80% predicted and a FEV1/Forced Vital Capacity (FVC) ratio >=0.7 at screening.
  • Alanine transaminase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper Limit Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Population
  • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
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  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and lung function testing. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and GSK medical monitor consider the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures and outcome.
  • Subjects who are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of <=10 pack years. [number of pack years = (number of cigarettes per day /20) x number of years smoked]
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • A female subject is eligible to participate as follows: Non-childbearing potential, females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods and women of childbearing potential should have used one of the contraception methods.
  • Body Mass Index (BMI) within the range 18.0-33.0 kg/m2 (inclusive).

Who cannot join

  • Safety
  • Lactating or pregnant females as determined by positive serum or urine hCG test at screening or Day -1.
  • A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
  • Hepatic Disease
  • 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. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
  • Concurrent Disease
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  • 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 HIV.
  • Concurrent Medication
  • 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 GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
  • Population
  • A positive pre-study drug/alcohol screen at screening and Day -1.
  • 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.
  • 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.
  • 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 any fruit juices containing these fruits from 7 days prior to the first dose of study medication and for the duration of the study.

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: An Open Label, Randomised, Four-Period Crossover, Single Dose Study in Healthy Volunteers to Evaluate the Pharmacokinetics of FF/UMEC/VI Combination Administered at Dose Levels 100/62.5/25 mcg and 100/125/25 mcg and in Comparison With FF/VI (100/25 mcg) and UMEC/VI (62.5/25 mcg).

This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram [mcg]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA).

Subjects will receive each of the four treatments once, separated by a wash-out period of 7-21 days between doses in a four way crossover design. There will be 4 treatment periods in total. During each treatment period, subjects will attend the clinical unit on Day -1 for standard safety assessments in addition to familiarization with the inhaler. Each subject will remain resident in the unit until at least 24 hours after the dose given on Day 1. Following completion of all four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication.

Being tested
FF 400 mcg, UMEC 500 mcg, UMEC 250 mcg, VI 100 mcg
Keywords
GW642444 (Vilanterol), GSK573719 (Umeclidinium), GW685698 (Fluticasone Furoate), pharmacokinetics, Healthy subjects
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.

  • FF 400 mcgDrug

    100 mcg powder for inhalation delivered by Dry Powder Inhaler (DPI)

  • UMEC 500 mcgDrug

    125 mcg powder for inhalation delivered by DPI

  • UMEC 250 mcgDrug

    62.5 mcg powder for inhalation delivered by DPI

  • VI 100 mcgDrug

    25 mcg powder for inhalation delivered by DPI

Study groups in NCT01894386
Study groupRoleWhat they receive
Sequence 1ExperimentalSubjects will receive treatment A, B, C, D in each dosing periods 1, 2, 3, and 4 respectively (one per period). A - FF/UMEC/VI 400/500/100; B - FF/UMEC/VI 400/250/100; C - FF/VI 400/100; D - UMEC/VI 250/100
Receives: Drug: FF 400 mcg; Drug: UMEC 500 mcg; Drug: UMEC 250 mcg; Drug: VI 100 mcg
Sequence 2ExperimentalSubjects will receive treatment B, D, A, C in each dosing periods 1, 2, 3, and 4 respectively (one per period). A - FF/UMEC/VI 400/500/100; B - FF/UMEC/VI 400/250/100; C - FF/VI 400/100; D - UMEC/VI 250/100
Receives: Drug: FF 400 mcg; Drug: UMEC 500 mcg; Drug: UMEC 250 mcg; Drug: VI 100 mcg
Sequence 3ExperimentalSubjects will receive treatment C, A, D, B in each dosing periods 1, 2, 3, and 4 respectively (one per period). Subjects will receive treatment B, D, A, C in each dosing periods 1, 2, 3, and 4 respectively (one per period). A - FF/UMEC/VI 400/500/100; B - FF/UMEC/VI 400/250/100; C - FF/VI 400/100; D - UMEC/VI 250/100
Receives: Drug: FF 400 mcg; Drug: UMEC 500 mcg; Drug: UMEC 250 mcg; Drug: VI 100 mcg
Sequence 4ExperimentalSubjects will receive treatment D, C, B, A in each dosing periods 1, 2, 3, and 4 respectively (one per period). Subjects will receive treatment C, A, D, B in each dosing periods 1, 2, 3, and 4 respectively (one per period). Subjects will receive treatment B, D, A, C in each dosing periods 1, 2, 3, and 4 respectively (one per period). A - FF/UMEC/VI 400/500/100; B - FF/UMEC/VI 400/250/100; C - FF/VI 400/100; D - UMEC/VI 250/100
Receives: Drug: FF 400 mcg; Drug: UMEC 500 mcg; Drug: UMEC 250 mcg; Drug: VI 100 mcg

What is being measured

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

  1. Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure.

    Area under the concentration time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) (or Area under the concentration time curve from time zero (pre-dose) to last common time of quantifiable concentration within a subject across all treatments [AUC(0-t')] if AUC(0-infinity) cannot be determined) and maximum observed concentration (Cmax) for each individual component (UMEC will be dose-normalised) across treatment groups will be estimated using the following treatment ratios: FF/UMEC/VI 100mcg/125mcg /25mcg Versus, FF/UMEC/VI 100mcg /62.5mcg /25mcg

    Measured: PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period

  2. Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg

    FF: FF/UMEC/VI versus FF/VI; UMEC: FF/UMEC/VI versus UMEC/VI; VI: FF/UMEC/VI versus FF/VI; VI: FF/UMEC/VI versus UMEC/VI

    Measured: PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.

Secondary outcomes (1)

  1. Composite of PK Parameters.

    Elimination half-life of a compound (t½) and Time after administration of a compound when the maximum plasma concentration is reached (tmax)

    Measured: PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.

Timeline

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

  1. First posted10 Jul 2013 (estimated)
  2. Study start15 Jul 2013
  3. Primary completion26 Sep 2013
  4. Study completion26 Sep 2013

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01894386
Sponsor's protocol ID
200587
Status last verified
May 2017
First submitted
3 Jul 2013
Last updated
15 May 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FF 400 mcg, UMEC 500 mcg and UMEC 250 mcg 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 11 inclusion and 17 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 15 May 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?

Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (time frame: PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period). The study lists 2 primary outcomes in all. 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 NCT01894386.

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 15 May 2017.

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