A First Time In Human Study To Assess The Compound GSK615915

Bronchospasm Clinical Trial

Official title:

First Time in Human, Single Dose and Repeat Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of GSK615915

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400660
• Other study ID #: OLA103920
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2006
• Last updated: September 27, 2017
• Start date: November 23, 2005
• Est. completion date: July 3, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 3, 2006
• Est. primary completion date: July 3, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchial Spasm
• Bronchospasm

Intervention

Drug:
• GSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
• Placebo
Subjects will also receive placebo inhaler.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Edinburgh	West Lothian

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)		Up to 18 weeks
Secondary	Levels of GSK615915A and any breakdown products in the blood and urine.		Up to 18 weeks

External Links

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