- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00400660
A First Time In Human Study To Assess The Compound GSK615915
September 27, 2017 updated by: GlaxoSmithKline
First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915
GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs).
A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.
Study Overview
Study Type
Interventional
Enrollment (Actual)
46
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
-
-
West Lothian
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Edinburgh, West Lothian, United Kingdom, EH14 4AP
- GSK Investigational Site
-
-
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
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Women of non-child bearing potential.
- 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
- The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years.
- The subject has demonstrated the ability to correctly use a metered dose inhaler device.
- If asthmatic:
The subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.
Exclusion Criteria:
- As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study.
- The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate.
- The subject has recently participated in another clinical trial.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 or 14 days.
- The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- 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 is has a positive drugs of abuse test.
- The subject has had a respiratory tract infection within 4 weeks of the start of the study.
- The subject has a past or present disease, which as judged by the Doctor, may affect the outcome of this study.
- The subject has a history of life-threatening asthma.
- 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 has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit.
- The subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit.
- The subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation.
- The subject has ongoing rhinitis that requires treatment.
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 Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Subjects receiving treatment sequence 1: Part 1
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
|
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Subjects will also receive placebo inhaler.
|
Experimental: Subjects receiving treatment sequence 2: Part 1
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
|
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Subjects will also receive placebo inhaler.
|
Experimental: Subjects receiving treatment sequence 1: Part 2
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
|
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Subjects will also receive placebo inhaler.
|
Experimental: Subjects receiving treatment sequence 2: Part 2
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
|
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Subjects will also receive placebo inhaler.
|
Experimental: Subjects receiving GSK615915A: Part 3
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms.
|
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
|
Experimental: Subjects receiving placebo: Part 3
Eligible subjects will receive placebo.
|
Subjects will also receive placebo inhaler.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
Time Frame: Up to 18 weeks
|
Up to 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Levels of GSK615915A and any breakdown products in the blood and urine.
Time Frame: Up to 18 weeks
|
Up to 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 23, 2005
Primary Completion (Actual)
July 3, 2006
Study Completion (Actual)
July 3, 2006
Study Registration Dates
First Submitted
November 15, 2006
First Submitted That Met QC Criteria
November 15, 2006
First Posted (Estimate)
November 17, 2006
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OLA103920
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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