A First Time In Human Study To Assess The Compound GSK615915

Study Overview
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Brief Summary
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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.

Official Title
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First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915

Conditions
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Bronchospasm

Intervention / Treatment
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* Drug: GSK615915A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Johnâ€™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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving treatment sequence 1: Part 1<br>Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. | Drug: GSK615915A<br>* GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.<br>Drug: Placebo<br>* Subjects will also receive placebo inhaler.<br>|
| Experimental: Subjects receiving treatment sequence 2: Part 1<br>Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. | Drug: GSK615915A<br>* GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.<br>Drug: Placebo<br>* Subjects will also receive placebo inhaler.<br>|
| Experimental: Subjects receiving treatment sequence 1: Part 2<br>Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. | Drug: GSK615915A<br>* GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.<br>Drug: Placebo<br>* Subjects will also receive placebo inhaler.<br>|
| Experimental: Subjects receiving treatment sequence 2: Part 2<br>Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. | Drug: GSK615915A<br>* GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.<br>Drug: Placebo<br>* Subjects will also receive placebo inhaler.<br>|
| Experimental: Subjects receiving GSK615915A: Part 3<br>Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms. | Drug: GSK615915A<br>* GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.<br>|
| Experimental: Subjects receiving placebo: Part 3<br>Eligible subjects will receive placebo. | Drug: Placebo<br>* Subjects will also receive placebo inhaler.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG) |  | Up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of GSK615915A and any breakdown products in the blood and urine. |  | Up to 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSK615915 asthma surfactant MDI