- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00625196
Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects
August 16, 2017 updated by: GlaxoSmithKline
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 Japanese Subjects
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 in healthy Japanese subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New South Wales
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Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion criteria:
- Healthy male adults aged between 20 and 60 years inclusive
- Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, and cardiac monitoring. 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 considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
- Male subjects must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control method the female partner is using, from the first dose of study medication until 90 days after the last dose of study medication.
- Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese)
- Body weight ≥ 45 kg and body mass index within the range of 18-28 kg/m2 inclusive.
No significant abnormality on 12-lead ECG at screening, including the following specific requirements:
- Ventricular rate ≥ 45 beats per minute
- PR interval ≤ 210msec
- Q waves < 30msec (up to 50 ms permitted in lead III only)
- QRS interval to be ≥ 60msec and ≤ 120msec
- The waveforms must enable the QT interval to be clearly defined
- QTc interval must be < 450msec (QTcB or QTcF; machine or manual reading) 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 ≥90% predicted and FEV1 / FVC ratio ≥ 0.7 at screening
- Subjects who are 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 < 5 pack years
- Signed and dated informed consent is obtained for the subject
- Subjects who are able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
- Subjects who are able to use the inhalation device satisfactorily
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principle 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.
- 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
- Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a 285mL glass of full strength beer or 425mL schooner of light beer or 1 (30mL) measure of spirits or 1 glass (100mL) of wine
- 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. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- 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, β2 agonist or sympathomimetic drug.
- Any known or suspected sensitivity to the constituents of GW642444M or GW685698X inhalation powder (i.e., lactose, magnesium stearate).
- Subjects at risk of non-compliance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Subjects receiving fluticasone foroate/ vilanterol
Eligible subjects will receive single dose of fluticasone foroate/ vilanterol combination treatment 800 micrograms/ 50 micrograms administered using a novel powder inhaler.
There will be a washout period of 7 to 10 days between treatments.
|
Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.
Fluticasone foroate 800 micrograms will be available as dry powder inhaler.
Vilanterol will be available as dry powder inhaler.
|
ACTIVE_COMPARATOR: Subjects receiving fluticasone foroate
Eligible subjects will receive single dose of fluticasone foroate 800 micrograms administered using a novel powder inhaler.
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Fluticasone foroate 800 micrograms will be available as dry powder inhaler.
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ACTIVE_COMPARATOR: Subjects receiving vilanterol
Eligible subjects will receive single dose of vilanterol 50 micrograms administered using a novel powder inhaler.
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Vilanterol will be available as dry powder inhaler.
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PLACEBO_COMPARATOR: Subjects receiving placebo
Eligible subjects will receive single dose of placebo administered using a novel powder inhaler.
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Placebo will be supplied as dry powder inhaler.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum heart rate
Time Frame: over 4 hours after dosing.
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over 4 hours after dosing.
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Blood pressure changes
Time Frame: over 12 hours.
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over 12 hours.
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Electrocardiogram changes
Time Frame: over 12 hours.
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over 12 hours.
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Change in peak expiry flow rate changes
Time Frame: over 24 hours.
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over 24 hours.
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Change in serum cortisol concentration changes
Time Frame: over 24 hours
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over 24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Time Frame: over 48 hours after dosing.
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over 48 hours after dosing.
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Change in blood potassium levels
Time Frame: within 4 hours of drug dosing.
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within 4 hours of drug dosing.
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Mean heart rate
Time Frame: over 4 hours after dosing
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over 4 hours after dosing
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Plasma concentrations and derived pharmacokinetic parameters (AUC, Cmax,t½, tmax) for GW685698X, GW642444 and the GW642444 inactive metabolites GW630200 and GSK932009
Time Frame: over 48 hours after dosing
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over 48 hours after dosing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 27, 2008
Primary Completion (ACTUAL)
May 6, 2008
Study Completion (ACTUAL)
May 6, 2008
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 27, 2008
First Posted (ESTIMATE)
February 28, 2008
Study Record Updates
Last Update Posted (ACTUAL)
August 21, 2017
Last Update Submitted That Met QC Criteria
August 16, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HZA102940
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Informed Consent Form
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: HZA102940Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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