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A First Time In Human Study To Assess The Compound GSK615915

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400660
First Posted: November 17, 2006
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: GSK615915A Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG) [ Time Frame: Up to 18 weeks ]

Secondary Outcome Measures:
  • Levels of GSK615915A and any breakdown products in the blood and urine. [ Time Frame: Up to 18 weeks ]

Enrollment: 46
Actual Study Start Date: November 23, 2005
Study Completion Date: July 3, 2006
Primary Completion Date: July 3, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subjects receiving treatment sequence 1: Part 1
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Drug: GSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Drug: Placebo
Subjects will also receive placebo inhaler.
Experimental: Subjects receiving treatment sequence 2: Part 1
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Drug: GSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Drug: Placebo
Subjects will also receive placebo inhaler.
Experimental: Subjects receiving treatment sequence 1: Part 2
Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Drug: GSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Drug: Placebo
Subjects will also receive placebo inhaler.
Experimental: Subjects receiving treatment sequence 2: Part 2
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Drug: GSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Drug: Placebo
Subjects will also receive placebo inhaler.
Experimental: Subjects receiving GSK615915A: Part 3
Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms.
Drug: GSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
Experimental: Subjects receiving placebo: Part 3
Eligible subjects will receive placebo.
Drug: Placebo
Subjects will also receive placebo inhaler.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00400660     History of Changes
Other Study ID Numbers: OLA103920
First Submitted: November 15, 2006
First Posted: November 17, 2006
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by GlaxoSmithKline:
GSK615915 asthma surfactant MDI

Additional relevant MeSH terms:
Bronchial Spasm
Bronchial Diseases
Respiratory Tract Diseases