Pulmonary Disease, Chronic ObstructivePhase 1NCT01449799
An Investigation of the Pharmacokinetics of GSK961081 and Fluticasone Propionate in Healthy Volunteers
A Phase 1 study testing GSK961081 800 microgram dose, Fluticasone Propionate 500 microgram dose and GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
In the current study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK961081 800 microgram dose, Fluticasone Propionate 500 microgram dose and GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jul 2011to 21 Sep 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the Investigator 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 agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures and outcome.
- A female subject of child bearing potential, is eligible if she agrees to use one of the contraception methods listed in Section 8.1 of the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for 5 half-lives after the end of the study (i.e. until after the follow-up visit is complete).
- Body Mass Index (BMI) within the range 19.0 - 29.9 kilogram per square meter (kg/m2) (inclusive).
- Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase and bilirubin less than 1.5 times the upper limit of normal (<1.5xULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35%).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
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- Forced Expiratory Volume in 1 second (FEV1) greater than or equal to 80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio greater than or equal to 0.7.
- 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 less than or equal to 10 pack years.
- [number of pack years = (number of cigarettes per day/20) x number of years smoked]
Who cannot join
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or electrocardiogram (ECG, 12-lead)
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (around 240 millilitres, ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- QTc value corrected for Bassett or Fredericia [QTc(B) and QTc(F)] at screening greater than 450 milliseconds on an individual ECG, the 3 screening ECGs are not within 10% of the mean QTC value, a PR interval outside the range 120-210 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- 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: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- 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.
- 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.
- Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 90 day period.
- Pregnant females as determined by positive serum Human Chorionic Gonadotrophin (hCG test) at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- A 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
- A positive test for human immunodeficiency virus (HIV) antibody.
- Urinary Cotinine/ Breath carbon monoxide (CO) levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Night shift workers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Double-dummy, Single Dose, Four Way Cross-over Study to Compare the Pharmacokinetics and Pharmacodynamics of GSK961081 and Fluticasone Propionate When Administered Alone, Concurrently and as a Combination Blend in Healthy Subjects
In the current study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. This is a single centre, randomized, double-blind, double dummy, single dose, four way cross-over study investigating the pharmacokinetics and pharmacodynamics of GSK961081 and fluticasone propionate when administered alone, concurrently and as a combination blend in healthy subjects.
Read the detailed description
This will be the first time that GSK961081 and fluticasone propionate will be administered as a blend in humans. In previous clinical studies conducted in Chronic Obstructive Pulmonary Disease (COPD) patients, GSK961081 has been administered on a background of fluticasone propionate without any observed systemic pharmacodynamic interaction. In this study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. The aim of the study will be to investigate any differences in pharmacodynamics and/or pharmacokinetics for GSK961081 and fluticasone propionate when administered as the blend, concurrently or alone.
Pharmacokinetic, pharmacodynamic and safety information will be gathered to assess the suitability of the GSK9610981/fluticasone propionate blend for further development.Each subject will receive four treatments (GSK961081 alone, fluticasone propionate alone, GSK961081 and fluticasone propionate concurrently, and GSK961081/fluticasone propionate blend) in randomized order, in four treatment periods, each separated by a washout period of at least a week. All treatments will be administered via a DISKUS inhaler.
Pharmacokinetics, pharmacodynamics and safety will be assessed by measurement of plasma GSK961081, plasma fluticasone propionate, serum cortisol, urine cortisol, blood glucose, serum potassium, Forced Expiratory Volume in one second (FEV1), heart rate, 12-lead Electrocardiograms (ECGs), clinical laboratory tests and collection of adverse events (AEs).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK961081 800 microgram dose, Fluticasone Propionate 500 microgram dose, GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately, GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend
- 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.
GSK961081 800 microgram doseDrug
To be provided via a combination of 4 inhalers - one 400 micrograms GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation and one inhalation each from two separate placebo Diskus inhalers
Fluticasone Propionate 500 microgram doseDrug
To be provided via a combination of 4 inhalers - one 250 microgram fluticasone propionate Diskus inhalation, a second 250 microgram fluticasone proopionate Diskus inhalation, and one inhalation each from two separate placebo Diskus inhalers
GSK961081 800 microgram and Fluticasone Propionate 500 microgram separatelyDrug
To be provided via a combination of 4 inhalers - one 400 microgram GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation, one 250 microgram fluticasone propionate Diskus inhalation, and a second fluticasone propionate 250 microgram Diskus inhalation
GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blendDrug
To be provided via a combination of 4 inhalers - one inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, a second inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, and one inhalation each from two separate placebo inhalers
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | In period 1, subjects will be administered GSK961081/fluticasone propionate blend via Diskus inhaler followed by the administration of GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers in period 2. In period 3 and period 4, the subjects will receive fluticasone propionate and GSK961081 respectively. Receives: Drug: GSK961081 800 microgram dose; Drug: Fluticasone Propionate 500 microgram dose; Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately; Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend |
| Sequence 2 | Experimental | In period 1, subjects will be administered GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers followed by administration of GSK961081 in period 2. In period 3 and period 4, the subjects will receive GSK961081/fluticasone propionate blend via Diskus inhaler followed by the administration of fluticasone propionate respectively. Receives: Drug: GSK961081 800 microgram dose; Drug: Fluticasone Propionate 500 microgram dose; Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately; Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend |
| Sequence 3 | Experimental | In period 1, subjects will be administered GSK961081 followed by administration of fluticasone propionate in period 2. In period 3, subjects will be administered GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers followed by GSK961081/fluticasone propionate blend via Diskus inhaler in period 4. Receives: Drug: GSK961081 800 microgram dose; Drug: Fluticasone Propionate 500 microgram dose; Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately; Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend |
| Sequence 4 | Experimental | In period 1, subjects will be administered fluticasone propionate followed by the administration of GSK961081/fluticasone propionate blend via Diskus inhaler in period 2. The subjects will receive GSK961081 in period 3 and concurrent administration of GSK961081 and fluticasone propionate in period 4. Receives: Drug: GSK961081 800 microgram dose; Drug: Fluticasone Propionate 500 microgram dose; Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately; Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plamsa concentrations and derived pharmacokinetic parameters of GSK961081 and fluticasone propionate
Maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve, and apparent terminal phase half-life (t1/2)] for GSK961081 and fluticasone propionate
Measured: From dosing to 24 hours post-dose
Secondary outcomes (3)
Serum Cortisol
Concentration of the hormone cortisol in serum
Measured: From dosing to 24 hours post-dose
Urinary Cortisol
Concentration of the hormone cortisol in urine
Measured: From dosing to 24 hours post-dose
Heart Rate Changes
The maximum change and weighted mean change in heart rate from baseline (pre-dose)
Measured: From dosing to 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study start13 Jul 2011
- Primary completion21 Sep 2011
- Study completion21 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449799
- Sponsor's protocol ID
- 113423
- Status last verified
- Jul 2017
- First submitted
- 6 Oct 2011
- Last updated
- 28 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.
Publications
Norris V, Ambery C, Riley T. Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist beta2 -agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers. Clin Pharmacol Drug Dev. 2014 Jul;3(4):305-13. doi: 10.1002/cpdd.105. Epub 2014 Feb 20.
PubMed 27128837
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double-dummy, Single Dose, Four Way Cross-over Study to Compare the Pharmacokinetics and Pharmacodynamics of GSK961081 and Fluticasone Propionate When Administered Alone, Concurrently and as a Combination Blend in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01449799
- Acronym / sponsor ID
- 113423
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2011 (actual)
- Primary completion
- 21 Sep 2011 (actual)
- Study completion
- 21 Sep 2011 (actual)
- First posted
- 10 Oct 2011 (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.
In the current study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. This is a single centre, randomized, double-blind, double dummy, single dose, four way cross-over study investigating the pharmacokinetics and pharmacodynamics of GSK961081 and fluticasone propionate when administered alone, concurrently and as a combination blend in healthy subjects.
Detailed description
This will be the first time that GSK961081 and fluticasone propionate will be administered as a blend in humans. In previous clinical studies conducted in Chronic Obstructive Pulmonary Disease (COPD) patients, GSK961081 has been administered on a background of fluticasone propionate without any observed systemic pharmacodynamic interaction. In this study GSK961081 and fluticasone propionate will be administered in a blended formulation from a single device and compared with GSK961081 and fluticasone propionate administered alone and concurrently. The aim of the study will be to investigate any differences in pharmacodynamics and/or pharmacokinetics for GSK961081 and fluticasone propionate when administered as the blend, concurrently or alone.
Pharmacokinetic, pharmacodynamic and safety information will be gathered to assess the suitability of the GSK9610981/fluticasone propionate blend for further development.Each subject will receive four treatments (GSK961081 alone, fluticasone propionate alone, GSK961081 and fluticasone propionate concurrently, and GSK961081/fluticasone propionate blend) in randomized order, in four treatment periods, each separated by a washout period of at least a week. All treatments will be administered via a DISKUS inhaler.
Pharmacokinetics, pharmacodynamics and safety will be assessed by measurement of plasma GSK961081, plasma fluticasone propionate, serum cortisol, urine cortisol, blood glucose, serum potassium, Forced Expiratory Volume in one second (FEV1), heart rate, 12-lead Electrocardiograms (ECGs), clinical laboratory tests and collection of adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: GSK961081 800 microgram dose, Drug: Fluticasone Propionate 500 microgram dose, Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately, Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blendIn period 1, subjects will be administered GSK961081/fluticasone propionate blend via Diskus inhaler followed by the administration of GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers in period 2. In period 3 and period 4, the subjects will receive fluticasone propionate and GSK961081 respectively. |
| Sequence 2 | Experimental | Drug: GSK961081 800 microgram dose, Drug: Fluticasone Propionate 500 microgram dose, Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately, Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blendIn period 1, subjects will be administered GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers followed by administration of GSK961081 in period 2. In period 3 and period 4, the subjects will receive GSK961081/fluticasone propionate blend via Diskus inhaler followed by the administration of fluticasone propionate respectively. |
| Sequence 3 | Experimental | Drug: GSK961081 800 microgram dose, Drug: Fluticasone Propionate 500 microgram dose, Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately, Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blendIn period 1, subjects will be administered GSK961081 followed by administration of fluticasone propionate in period 2. In period 3, subjects will be administered GSK961081 and fluticasone propionate concurrently via separate Diskus inhalers followed by GSK961081/fluticasone propionate blend via Diskus inhaler in period 4. |
| Sequence 4 | Experimental | Drug: GSK961081 800 microgram dose, Drug: Fluticasone Propionate 500 microgram dose, Drug: GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately, Drug: GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blendIn period 1, subjects will be administered fluticasone propionate followed by the administration of GSK961081/fluticasone propionate blend via Diskus inhaler in period 2. The subjects will receive GSK961081 in period 3 and concurrent administration of GSK961081 and fluticasone propionate in period 4. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the Investigator 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 agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures and outcome.
- A female subject of child bearing potential, is eligible if she agrees to use one of the contraception methods listed in Section 8.1 of the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception for 5 half-lives after the end of the study (i.e. until after the follow-up visit is complete).
- Body Mass Index (BMI) within the range 19.0 - 29.9 kilogram per square meter (kg/m2) (inclusive).
- Aspartate Transaminase (AST), Alanine Transaminase (ALT), alkaline phosphatase and bilirubin less than 1.5 times the upper limit of normal (<1.5xULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35%).
Key exclusion criteria (19 listed)
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or electrocardiogram (ECG, 12-lead)
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (around 240 millilitres, ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- QTc value corrected for Bassett or Fredericia [QTc(B) and QTc(F)] at screening greater than 450 milliseconds on an individual ECG, the 3 screening ECGs are not within 10% of the mean QTC value, a PR interval outside the range 120-210 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
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 |
|---|---|---|
| GSK961081 800 microgram doseTo be provided via a combination of 4 inhalers - one 400 micrograms GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation and one inhalation each from two separate placebo Diskus inhalers | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Fluticasone Propionate 500 microgram doseTo be provided via a combination of 4 inhalers - one 250 microgram fluticasone propionate Diskus inhalation, a second 250 microgram fluticasone proopionate Diskus inhalation, and one inhalation each from two separate placebo Diskus inhalers | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| GSK961081 800 microgram and Fluticasone Propionate 500 microgram separatelyTo be provided via a combination of 4 inhalers - one 400 microgram GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation, one 250 microgram fluticasone propionate Diskus inhalation, and a second fluticasone propionate 250 microgram Diskus inhalation | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blendTo be provided via a combination of 4 inhalers - one inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, a second inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, and one inhalation each from two separate placebo inhalers | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Plamsa concentrations and derived pharmacokinetic parameters of GSK961081 and fluticasone propionate
Time frame: From dosing to 24 hours post-dose
Maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve, and apparent terminal phase half-life (t1/2)] for GSK961081 and fluticasone propionate
3 secondary outcomes
Serum Cortisol
Time frame: From dosing to 24 hours post-dose
Urinary Cortisol
Time frame: From dosing to 24 hours post-dose
Heart Rate Changes
Time frame: From dosing to 4 hours post-dose
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 28 Jul 2017.
- Derived from this study: PubMed 27128837Norris V, Ambery C, Riley T. Pharmacokinetics and pharmacodynamics of GSK961081, a novel inhaled muscarinic antagonist beta2 -agonist, and fluticasone propionate administered alone, concurrently and as a combination blend formulation in healthy volunteers. Clin Pharmacol Drug Dev. 2014 Jul;3(4):305-13. doi: 10.1002/cpdd.105. Epub 2014 Feb 20.
- Results for study 113423 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 GSK961081 800 microgram dose, Fluticasone Propionate 500 microgram dose and GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
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 19 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 28 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 Kingdom. 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?
Plamsa concentrations and derived pharmacokinetic parameters of GSK961081 and fluticasone propionate (time frame: From dosing to 24 hours post-dose). 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 NCT01449799, which also lists 1 linked publication.
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 28 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.