A First Time In Human Study To Assess The Compound GSK615915

Phase 1

Completed

• Conditions: Bronchospasm
• Interventions: Drug: GSK615915A; Drug: Placebo

• Registration Number: NCT00400660
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-23
• Primary Completion: 2006-07-03
• Study Completion: 2006-07-03
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-17
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Subjects receiving treatment sequence 1: Part 2	Placebo	Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 1: Part 1	Placebo	Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 2: Part 1	Placebo	Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Subjects receiving GSK615915A: Part 3	GSK615915A	Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 2: Part 1	GSK615915A	Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Subjects receiving treatment sequence 2: Part 2	Placebo	Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Subjects receiving treatment sequence 1: Part 2	GSK615915A	Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 1: Part 1	GSK615915A	Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 2: Part 2	GSK615915A	Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Subjects receiving placebo: Part 3	Placebo	Eligible subjects will receive placebo.

Primary Outcome Measures

Name	Time	Method
Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)	Up to 18 weeks

Secondary Outcome Measures

Name	Time	Method
Levels of GSK615915A and any breakdown products in the blood and urine.	Up to 18 weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Edinburgh, West Lothian, United Kingdom