Clinical trial NCT00400660: A First Time In Human Study To Assess The Compound GSK615915
Official title: First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bronchospasm
Keywords: GSK615915 asthma surfactant MDI
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Levels of GSK615915A and any breakdown products in the blood and urine.
timeFrame: Up to 18 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: West Lothian
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: