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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00538057




Registration number
NCT00538057
Ethics application status
Date submitted
1/10/2007
Date registered
2/10/2007
Date last updated
4/08/2017

Titles & IDs
Public title
Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
Scientific title
A Randomised, Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of GW685698X and GW642444M When Administered Separately and in Combination as a Single Dose From a Novel Dry Powder Device in Healthy Subjects
Secondary ID [1] 0 0
HZA105871
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 - GW685698X & GW642444M

Experimental: arm 1 - study drug


Treatment: Drugs: GW685698X & GW642444M
study drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum heart rate
Timepoint [1] 0 0
over 4 hours after dosing.
Primary outcome [2] 0 0
Blood pressure
Timepoint [2] 0 0
changes over 12 hours.
Primary outcome [3] 0 0
Electrocardiogram
Timepoint [3] 0 0
changes over 12 hours.
Primary outcome [4] 0 0
Change in peak expiry flow rate
Timepoint [4] 0 0
changes over 24 hours.
Primary outcome [5] 0 0
Change in serum cortisol concentration
Timepoint [5] 0 0
changes over 24 hours.
Secondary outcome [1] 0 0
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Timepoint [1] 0 0
over 48 hours after dosing.
Secondary outcome [2] 0 0
Change in blood potassium levels
Timepoint [2] 0 0
within 4 hours of drug dosing.
Secondary outcome [3] 0 0
Mean heart rate
Timepoint [3] 0 0
over 4 hours after dosing

Eligibility
Key inclusion criteria
Inclusion criteria:

* Healthy adults aged between 18 and 60 years.
* Male subjects or female subjects of non child bearing potential.
* Body weight at least 50 kg and BMI within the range of 19-31 kg/m2 inclusive.
* No significant abnormality from ECG at screening.
* FEV1 at least 90% predicted and FEV1 / FVC ratio at least 0.7 at screening.
* Current non-smokers who have not used any tobacco products in the 12 month period preceding the screening visit and have a pack history of equal to or less than 5 pack years.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria:

* Systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
* The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
* Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
* Liver function tests (AST, ALT or ALP) greater than 1.5 of the upper limit of laboratory reference range.
* 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 physician responsible, contraindicates their participation.
* History of milk protein allergy.
* The subject has taken 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 the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor 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 a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* The subject has donated a unit (450mL) of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
* 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.
* The subject has a positive pre-study urine drug screen.
* Positive CO or alcohol breath test at screening or on admission to the Unit.
* History of any adverse reaction including immediate or delayed hypersensitivity to any ICS, ß2-agonist or sympathomimetic drug. gefitinib or erlotinib) is permitted. Use of bevacizumab must have ended at least 40 days prior to date of first dose of study drug.
* Any anti-cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy) currently or within 14 days prior to date of first dose of study drug.
* Any ongoing toxicity from prior anti-cancer therapy that is greater than Grade 1 and/or that is progressing in severity.
* Known immediate or delayed hypersensitivity reaction or idiosyncracy to drugs chemically related to pazopanib.

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
2/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.
Trial website
https://clinicaltrials.gov/study/NCT00538057
Trial related presentations / publications
This study has not been published in the scientific literature.
Kempsford R, Allen A, Bareille P, Hamilton M, Cheesbrough A. The pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharmacol Drug Dev. 2015 Jan;4(1):2-11. doi: 10.1002/cpdd.160. Epub 2014 Dec 5.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00538057