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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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:
ClinicalTrials.gov processed this record on February 27, 2015
GSK615915 asthma surfactant MDI