Last updated: 11/04/2018 10:02:57

A First Time In Human Study To Assess The Compound GSK615915

GSK study ID
OLA103920
See study documents
Clinicaltrials.gov ID
NCT00400660
EudraCT ID
2005-003546-34
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: First time in human, single dose and repeat dose study to assess the safety, tolerability and pharmacokinetics of GSK615915
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)

Timeframe: Up to 18 weeks

Secondary outcomes:

Levels of GSK615915A and any breakdown products in the blood and urine.

Timeframe: Up to 18 weeks

Interventions:
Drug: GSK615915A
Drug: Placebo
Enrollment:
46
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bronchospasm
Product
GSK615915
Collaborators
Not applicable
Study date(s)
November 2005 to July 2006
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
  • 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
  • As a result of the medical interview, physical examination or screening
  • investigations, the Physician Responsible considers the volunteer unfit for the study.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Edinburgh, West Lothian, United Kingdom, EH14 4AP
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-03-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study OLA103920 can be found on the GSK Clinical Study Register.
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