A First Time In Human Study To Assess The Compound GSK615915

NCT ID: NCT00400660

Last Updated: 2017-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-23
• Study Completion Date: 2006-07-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT

Study Groups

Subjects receiving treatment sequence 1: Part 1

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

Group Type: EXPERIMENTAL

GSK615915A

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Subjects will also receive placebo inhaler.

Subjects receiving treatment sequence 2: Part 1

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

Group Type: EXPERIMENTAL

GSK615915A

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Subjects will also receive placebo inhaler.

Subjects receiving treatment sequence 1: Part 2

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

Group Type: EXPERIMENTAL

GSK615915A

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Subjects will also receive placebo inhaler.

Subjects receiving treatment sequence 2: Part 2

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

Group Type: EXPERIMENTAL

GSK615915A

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Subjects will also receive placebo inhaler.

Subjects receiving GSK615915A: Part 3

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

Group Type: EXPERIMENTAL

GSK615915A

Intervention Type: DRUG

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

Subjects receiving placebo: Part 3

Eligible subjects will receive placebo.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Subjects will also receive placebo inhaler.

Interventions

GSK615915A

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

Intervention Type: DRUG

Placebo

Subjects will also receive placebo inhaler.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Edinburgh, West Lothian, United Kingdom

Countries

United Kingdom

Other Identifiers

OLA103920

Identifier Type: -

Identifier Source: org_study_id