A First Time In Human Study To Assess The Compound GSK615915
This study has been completed.
Information provided by (Responsible Party):
First received: November 15, 2006
Last updated: May 31, 2012
Last verified: February 2011
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.
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||A Randomised, Single and Repeat Dose, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915 in Healthy Volunteers and Mild Asthmatics.
Primary Outcome Measures:
- Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
Secondary Outcome Measures:
- Levels of GSK615915A and any breakdown products in the blood and urine.
| Estimated Enrollment:
| Study Start Date:
Other Name: GSK615915
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400660
|GSK Investigational Site
|Edinburgh, West Lothian, United Kingdom, EH14 4AP |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 15, 2006
||May 31, 2012
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by GlaxoSmithKline:
GSK615915 asthma surfactant MDI
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases