A First Time In Human Study To Assess The Compound GSK615915
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00400660
First received: November 15, 2006
Last updated: May 31, 2012
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchospasm Asthma |
Drug: GSK615915 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
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: | 54 |
| Study Start Date: | November 2005 |
Intervention Details:
-
Drug: GSK615915
Other Name: GSK615915
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00400660 History of Changes |
| Other Study ID Numbers: | OLA103920 |
| Study First Received: | November 15, 2006 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
GSK615915 asthma surfactant MDI |
Additional relevant MeSH terms:
|
Asthma Bronchial Spasm Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013