A First Time In Human Study To Assess The Compound GSK615915

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00400660
First received: November 15, 2006
Last updated: May 31, 2012
Last verified: February 2011
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400660

Locations
United Kingdom
GSK Investigational Site
Edinburgh, West Lothian, United Kingdom, EH14 4AP
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  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 April 15, 2014