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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01000597




Registration number
NCT01000597
Ethics application status
Date submitted
22/10/2009
Date registered
23/10/2009

Titles & IDs
Public title
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate is Processed by the Body in Healthy Caucasian, Japanese, Korean and Chinese Subjects
Scientific title
An Open-label, Randomised, Two-way Crossover Study, to Evaluate and Compare the Pharmacokinetics of Fluticasone Furoate, Administered From a Novel Dry Powder Device (Repeat Dose) and Intravenously (Single Dose), in Healthy Caucasian, Japanese, Korean and Chinese Subjects
Secondary ID [1] 0 0
113477
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - fluticasone furoate

Other: Treatment Y - Seven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2).

Other: Treatment Z - A single intravenous dose of 250mcg FF given over 20 minutes (Day 1).


Treatment: Drugs: fluticasone furoate
Seven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2).

A single intravenous dose of 250mcg FF given over 20 minutes (Day 1).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FF Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax for inhaled and intravenous treatments. Volume of distribution (V) and plasma clearance (CL) for intravenous FF
Timepoint [1] 0 0
up to 72hr PK sampling periods profiles on 4 separate occasions over a total period of approximately 4-5 weeks
Secondary outcome [1] 0 0
Pharmacokinetic parameters MRT for both inhaled and intravenous treatments; MAT, AUC(0-t) for 200mcg dose,observed accumulation (Ro) and absolute bioavailability for inhaled treatment
Timepoint [1] 0 0
up to 72hr PK sampling periods profiles on 4 separate occasions over a total period of approximately 4-5 weeks
Secondary outcome [2] 0 0
Pharmacodynamics; serum cortisol for 200mcg inhaled FF treatment only: 24 hour weighted mean (on Day -1 and Day 7)
Timepoint [2] 0 0
Two 24 hour sampling periods approximately 1 week apart
Secondary outcome [3] 0 0
• Ratio of twenty-four hour urine cortisol to 6-beta-hydroxy-cortisol (on Day -1 of first treatment period only). Plasma 4-beta-hydroxy-cholesterol (single sample, on Day -1 of first treatment period only). Measure of baseline CYP3A4 activity
Timepoint [3] 0 0
One collection period of up to 24 hours
Secondary outcome [4] 0 0
• Vital signs, 12-lead ECG, Clinical laboratory tests, forced expiratory volume in 1 second (FEV1) (at screening), peak expiratory flow rate (PEFR), AEs.
Timepoint [4] 0 0
Throughout study; approx 10 weeks
Secondary outcome [5] 0 0
Quantity of the total emitted dose (TED), ex-throat dose (ETD) and mass less than 2 micrometer of inhaled FF for each subject, assessed by pharyngometry, inhalation profile, breath hold and lung volume measurements
Timepoint [5] 0 0
Throughout study from screening to end of treatment periods; approximately 8 weeks

Eligibility
Key inclusion criteria
* Healthy male or female between 20 and 64 years of age inclusive
* Caucasian, Japanese, Korean or Chinese
* Body mass index (BMI) for Caucasians within the range 18.5-29.0 kg/m2 (inclusive). For East Asians BMI within the range 18.5-24.9 kg/m2 (inclusive) and height 1.55m-1.85m (inclusive)
* Non-smokers
* AST, ALT, alkaline phosphatase and bilirubin </=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
* No significant abnormality on 12-lead ECG at screening
* No significant abnormality on the Holter ECG at screening
* FEV1 >/= 85% predicted at screening
* Capable of giving written informed consent
* Subjects who are able to use the inhalation device satisfactorily
Minimum age
20 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* As a result of screening medical exam, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
* Any history of breathing problems in adult life
* Pregnant or lactating females
* Subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
* 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.
* History of milk protein allergy.
* 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.
* Subject has taken oral corticosteroids less than 8 weeks before the screening visit.
* Subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
* History of alcohol/drug abuse or dependence within 12 months of the study
* 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).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* Positive for HIV antibodies.
* Positive pre-study urine drug screen or when randomly tested during the study.
* Positive carbon monoxide or alcohol breath test at screening or on admission to the Unit.
* Positive urine cotinine test at screening.
* Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subject is mentally or legally incapacitated.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2009
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01000597