A First Time In Human Study To Assess The Compound GSK615915

NCT00400660 | Completed Phase 1

• 1 other identifier: OLA103920
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchospasm

Keywords

GSK615915 asthma surfactant MDI

Outcome Measures

Primary Outcomes (1)

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

  Up to 18 weeks

Secondary Outcomes (1)

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

  Up to 18 weeks

Study Arms (6)

Subjects receiving treatment sequence 1: Part 1

EXPERIMENTAL

Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.

Drug: GSK615915A; Drug: Placebo

Subjects receiving treatment sequence 2: Part 1

EXPERIMENTAL

Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.

Drug: GSK615915A; Drug: Placebo

Subjects receiving treatment sequence 1: Part 2

EXPERIMENTAL

Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.

Drug: GSK615915A; Drug: Placebo

Subjects receiving treatment sequence 2: Part 2

EXPERIMENTAL

Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.

Drug: GSK615915A; Drug: Placebo

Subjects receiving GSK615915A: Part 3

EXPERIMENTAL

Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms.

Drug: GSK615915A

Subjects receiving placebo: Part 3

EXPERIMENTAL

Eligible subjects will receive placebo.

Drug: Placebo

Interventions

GSK615915A DRUG

GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.

Subjects receiving GSK615915A: Part 3; Subjects receiving treatment sequence 1: Part 1; Subjects receiving treatment sequence 1: Part 2; Subjects receiving treatment sequence 2: Part 1; Subjects receiving treatment sequence 2: Part 2

Placebo DRUG

Subjects will also receive placebo inhaler.

Subjects receiving placebo: Part 3; Subjects receiving treatment sequence 1: Part 1; Subjects receiving treatment sequence 1: Part 2; Subjects receiving treatment sequence 2: Part 1; Subjects receiving treatment sequence 2: Part 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Edinburgh, West Lothian, EH14 4AP, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Bronchial Spasm

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 17, 2006
• Study Start: November 23, 2005
• Primary Completion: July 3, 2006
• Study Completion: July 3, 2006
• Last Updated: September 29, 2017

Record last verified: 2017-09

Locations

GB (1)