The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
NCT ID: NCT00453791
Last Updated: 2017-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
31 participants
INTERVENTIONAL
2006-02-07
2006-04-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
Study Groups
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Subjects receiving treatment sequence 1: Part 1
Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using Metered Dose Inhaler (MDI).
GW805858
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Placebo
Placebo MDI will be given to the subjects.
Subjects receiving treatment sequence 2: Part 1
Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.
GW805858
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Placebo
Placebo MDI will be given to the subjects.
Subjects receiving treatment sequence 1: Part 2
Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using MDI.
GW805858
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Placebo
Placebo MDI will be given to the subjects.
Subjects receiving treatment sequence 2: Part 2
Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.
GW805858
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Placebo
Placebo MDI will be given to the subjects.
Subjects receiving GW805858: Part 3
Eligible subjects will receive GW805858 1200 micrograms twice daily administered using MDI.
GW805858
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Subjects receiving placebo: Part 3
Eligible subjects will receive placebo administered using MDI.
Placebo
Placebo MDI will be given to the subjects.
Interventions
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GW805858
GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Placebo
Placebo MDI will be given to the subjects.
Eligibility Criteria
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Inclusion Criteria
* Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive.
* The subject is a current non-smoker who has not used any tobacco products in the last year.
* A signed and dated written informed consent is obtained for the subject.
* The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
* If asthmatic, the subject must be a clinically stable asthmatic.
Exclusion Criteria
* The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication.
* The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
* The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female.
* The subject has any history of breathing problems (e.g. history of asthmatic symptoms).
* The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
* The subject has had a respiratory tract infection or worsening of asthma within 4 weeks of the start of the study.
* The subject has a past or present disease, which as judged by the Investigator, may affect the outcome of this study.
* The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxia seizures.
* The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.
* The subject is unable to abstain from other drugs that may interfere with the conduct of the study.
* The subject has ongoing rhinitis that requires treatment.
18 Years
60 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
London, , United Kingdom
Countries
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Other Identifiers
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SF2105450
Identifier Type: -
Identifier Source: org_study_id