Back to resultsThe Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
Primary Purpose
Asthma
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GW805858
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring GW805858, MDI, asthma, surfactant
Eligibility Criteria
Inclusion Criteria:
- Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
- 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 a history of allergy to ingredients within the inhaler.
- 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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Subjects receiving treatment sequence 1: Part 1
Subjects receiving treatment sequence 2: Part 1
Subjects receiving treatment sequence 1: Part 2
Subjects receiving treatment sequence 2: Part 2
Subjects receiving GW805858: Part 3
Subjects receiving placebo: Part 3
Arm Description
Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using Metered Dose Inhaler (MDI).
Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.
Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using MDI.
Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.
Eligible subjects will receive GW805858 1200 micrograms twice daily administered using MDI.
Eligible subjects will receive placebo administered using MDI.
Outcomes
Primary Outcome Measures
Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.
Secondary Outcome Measures
Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453791
Brief Title
The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
Official Title
A Randomised, Single and Repeat Dose, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Study Start Date
February 7, 2006 (Actual)
Primary Completion Date
April 10, 2006 (Actual)
Study Completion Date
April 10, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
GW805858, MDI, asthma, surfactant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving treatment sequence 1: Part 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using Metered Dose Inhaler (MDI).
Arm Title
Subjects receiving treatment sequence 2: Part 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.
Arm Title
Subjects receiving treatment sequence 1: Part 2
Arm Type
Experimental
Arm Description
Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using MDI.
Arm Title
Subjects receiving treatment sequence 2: Part 2
Arm Type
Experimental
Arm Description
Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.
Arm Title
Subjects receiving GW805858: Part 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive GW805858 1200 micrograms twice daily administered using MDI.
Arm Title
Subjects receiving placebo: Part 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive placebo administered using MDI.
Intervention Type
Drug
Intervention Name(s)
GW805858
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo MDI will be given to the subjects.
Primary Outcome Measure Information:
Title
Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.
Time Frame
Up to 18 weeks
Secondary Outcome Measure Information:
Title
Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.
Time Frame
Pre-dose, 5,20,30,45,60,90 minutes, 2,3,4,6,8,10,12,12.5,13,14, 24 hours Post-dose on Days 1 and 28.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
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 a history of allergy to ingredients within the inhaler.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW20 0NE
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics
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