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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01299558




Registration number
NCT01299558
Ethics application status
Date submitted
10/06/2010
Date registered
18/02/2011

Titles & IDs
Public title
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects
Scientific title
An Open-label, Non-randomised, Three-way Crossover, Single Dose Study to Determine the Absolute Bioavailability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder, in Healthy Subjects
Secondary ID [1] 0 0
102934
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//GW642444
Treatment: Drugs - fluticasone furoate
Treatment: Drugs - GW642444

Other: Treatment period 1 - Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1

Other: Treatment Period 2 - Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2

Other: Treatment Period 3 - Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3


Treatment: Drugs: fluticasone furoate//GW642444
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning

Treatment: Drugs: fluticasone furoate
Single IV dose of FF (250mcg)

Treatment: Drugs: GW642444
Single IV dose of GW642444 (55mcg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously
Timepoint [1] 0 0
Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
Secondary outcome [1] 0 0
Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments
Timepoint [1] 0 0
Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
Secondary outcome [2] 0 0
Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability
Timepoint [2] 0 0
Approximately 9 weeks for each subject
Secondary outcome [3] 0 0
Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability
Timepoint [3] 0 0
Approximately 9 weeks for each subject
Secondary outcome [4] 0 0
Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability
Timepoint [4] 0 0
Approximately 9 weeks for each subject
Secondary outcome [5] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timepoint [5] 0 0
Approximately 9 weeks for each subject

Eligibility
Key inclusion criteria
* Healthy male or female between 18 and 64 years of age inclusive
* Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
* Subjects who are current non-smokers
* AST, ALT, alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
* QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
* No significant abnormality on the Holter ECG at screening
* FEV1 = 85% predicted at screening.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Subjects who are able to use the inhalation device satisfactorily
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* As a result of medical interview, physical examination or screening investigations, 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
* Any history of breathing problems in adult life
* Pregnant or lactating females
* The 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 a lower respiratory tract infection within 4 weeks of the screening visit
* Subjects with recent history (within 6 months) of pneumonia
* 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
* Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
* 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
* The subject has taken oral corticosteroids less than 8 weeks before the screening visit
* The 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
* 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)
* 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
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* The subject has tested positive for HIV antibodies
* A positive pre-study urine drug screen or when randomly tested during the study
* Positive carbon monoxide (CO) 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
Non-randomised 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
17/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/07/2010
Sample size
Target
Accrual to date
Final
16
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/NCT01299558