AsthmaPhase 1NCT01669070
A Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate Inhalation Powder Administered by Novel Dry Powder Inhaler (NDPI)
A Phase 1 study testing FF, 50 mcg, FF, 100 mcg and FF, 200 mcg in people with Asthma, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- FF, 50 mcg, FF, 100 mcg and FF, 200 mcg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Aug 2012to 16 Nov 2012
- 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 male or female subjects between 18 and 65 years of age and body mass index (BMI) within the range 18.5 to 29.0 kilogram/meter squared.
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and bilirubin < or =1.5x upper limit of normal (ULN).
- Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
- Average QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 millisecond.
- Forced Expiratory Volume in 1 Second (FEV1) > or = 85% predicted at screening.
- Current non-smokers
- Able to satisfactorily use the NDPI.
Who cannot join
- Subjects must not have a systolic blood pressure above 145 milimeter(mm) of mercury(Hg) or a diastolic pressure above 85 mmHg at the screening visit.
- History of breathing problems in adult life confirmed by normal lung function parameters (≥85% predicted).
- Donation of more than 500 mL blood within a 56 day period.
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
- The subject treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
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- The subject has a positive: drug/alcohol, Hepatitis, HIV screen.
- Abuse of alcohol.
- Subject having positive cotinine and urine alcohol test.
- Participated in >3 clinical trials in the previous 10 months (if male), or >2 clinical trials in the previous 10 months (if female), or the subject has participated in a study (including follow up) within 60 days prior to the first dosing day in the current study.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Taken systemic, oral or depot corticosteroids less than 12 weeks or inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
- Use of prescription or non-prescription drugs.
- History of severe milk protein allergy, sensitivity to any of the study medications, including immediate or delayed hypersensitivity to any intranasal, inhaled or systemic corticosteroid therapy.
- Pregnant or lactating females.
- 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.
About this study
Official title: 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
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.
- Conditions
- Asthma
- Being tested
- FF, 50 mcg, FF, 100 mcg, FF, 200 mcg, FF, 250 mcg
- Keywords
- bioavailability, Fluticasone Furoate, pharmacokinetics, dose proportionality
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FF, 50 mcgDrug
Novel dry powder inhaler
FF, 100 mcgDrug
Novel dry powder inhaler
FF, 200 mcgDrug
Novel dry powder inhaler
FF, 250 mcgDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| FF 50 mcg powder inhalation | 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. Receives: Drug: FF, 50 mcg |
| FF 100 mcg powder inhalation | 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. Receives: Drug: FF, 100 mcg |
| FF 200 mcg powder inhalation | 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. Receives: Drug: FF, 200 mcg |
| FF 250 mcg 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. Receives: Drug: FF, 250 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
FF pharmacokinetics; parameters: (AUC(0-infinity)) , (AUC(0-24)) and (Cmax)
FF pharmacokinetics; area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC (0-infinity)), area under the concentration-time curve from zero (pre-dose) to 24 h (AUC (0-24)) and maximum observed concentration (Cmax). Blood samples for PK analysis of FF will be collected and analysis will be performed. Concentrations of FF will be determined in plasma samples using the currently approved analytical methodology.
Measured: 54 days
Secondary outcomes (4)
Plasma FF PK parameters: t1/2, tmax, MRT for all treatments
Following plasma FF PK parameters will be evaluated: terminal phase half life (t1/2), time of occurrence of Cmax (tmax), mean residence time (MRT) for all treatments Blood samples for PK analysis of FF will be collected and analysis will be performed. Concentrations of FF will be determined in plasma samples using the currently approved analytical methodology.
Measured: 54 days
Plasma FF PK parameters: V and CL for IV treatment
Following plasma FF PK parameters will be evaluated: volume of distribution (V) and plasma clearance (CL) for intravenous administration Blood samples for PK analysis of FF will be collected and analysis will be performed. Concentrations of FF will be determined in plasma samples using the currently approved analytical methodology.
Measured: 3 days (Study Day 52 to Study Day 54)
Mean absorption time (MAT) for inhaled treatments
Blood samples for PK analysis of FF will be collected and analysis will be performed. Concentrations of FF will be determined in plasma samples using the currently approved analytical methodology.
Measured: 44 days
Safety of FF
To assess the safety and tolerability of FF administered as single and repeat dose adverse events will be studied.
Measured: 68 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start15 Aug 2012
- Primary completion16 Nov 2012
- Study completion16 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- None (open label)
- Enrolment
- 36 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
- NCT01669070
- Sponsor's protocol ID
- 115441
- Status last verified
- Jun 2017
- First submitted
- 16 Aug 2012
- Last updated
- 12 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01669070
- Acronym / sponsor ID
- 115441
- Conditions
- Asthma
- Keywords
- bioavailability, Fluticasone Furoate, pharmacokinetics, dose proportionality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2012 (actual)
- Primary completion
- 16 Nov 2012 (actual)
- Study completion
- 16 Nov 2012 (actual)
- First posted
- 20 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FF 50 mcg powder inhalation | Experimental | Drug: FF, 50 mcgEach 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. |
| FF 100 mcg powder inhalation | Experimental | Drug: FF, 100 mcgEach 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. |
| FF 200 mcg powder inhalation | Experimental | Drug: FF, 200 mcgEach 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. |
| FF 250 mcg IV | Experimental | Drug: FF, 250 mcgEach 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male or female subjects between 18 and 65 years of age and body mass index (BMI) within the range 18.5 to 29.0 kilogram/meter squared.
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and bilirubin < or =1.5x upper limit of normal (ULN).
- Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study.
- Average QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 millisecond.
- Forced Expiratory Volume in 1 Second (FEV1) > or = 85% predicted at screening.
Key exclusion criteria (17 listed)
- Subjects must not have a systolic blood pressure above 145 milimeter(mm) of mercury(Hg) or a diastolic pressure above 85 mmHg at the screening visit.
- History of breathing problems in adult life confirmed by normal lung function parameters (≥85% predicted).
- Donation of more than 500 mL blood within a 56 day period.
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
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 |
|---|---|---|
| FF, 50 mcgNovel dry powder inhaler | Drug | FF 50 mcg powder inhalation |
| FF, 100 mcgNovel dry powder inhaler | Drug | FF 100 mcg powder inhalation |
| FF, 200 mcgNovel dry powder inhaler | Drug | FF 200 mcg powder inhalation |
| FF, 250 mcgIntravenous | Drug | FF 250 mcg IV |
Primary outcome
FF pharmacokinetics; parameters: (AUC(0-infinity)) , (AUC(0-24)) and (Cmax)
Time frame: 54 days
FF pharmacokinetics; area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC (0-infinity)), area under the concentration-time curve from zero (pre-dose) to 24 h (AUC (0-24)) and maximum observed concentration (Cmax). Blood samples for PK analysis of FF will be collected and analysis will be performed. Concentrations of FF will be determined in plasma samples using the currently approved analytical methodology.
4 secondary outcomes
Plasma FF PK parameters: t1/2, tmax, MRT for all treatments
Time frame: 54 days
Plasma FF PK parameters: V and CL for IV treatment
Time frame: 3 days (Study Day 52 to Study Day 54)
Mean absorption time (MAT) for inhaled treatments
Time frame: 44 days
Safety of FF
Time frame: 68 days
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 12 Jun 2017.
- Results for study 115441 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 FF, 50 mcg, FF, 100 mcg and FF, 200 mcg in people with Asthma, run by GlaxoSmithKline at 1 site in Netherlands.
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 7 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 12 Jun 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 Netherlands. 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?
FF pharmacokinetics; parameters: (AUC(0-infinity)) , (AUC(0-24)) and (Cmax) (time frame: 54 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2017.