GSK159802 In Healthy Male Subjects And Asthmatics
A Randomised, Double Blind, Placebo Controlled Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Profile of Single Inhaled Dry Powder Doses of GSK159802 in Healthy Male Subjects
1 other identifier
interventional
43
1 country
2
Brief Summary
GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis. The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2005
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2006
CompletedFirst Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedSeptember 29, 2017
September 1, 2017
11 months
August 11, 2006
September 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety & tolerability of single inhaled doses of GSK159802.
Up to 71 days
Secondary Outcomes (1)
sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure
Up to 71 days
Study Arms (14)
Subjects receiving treatment sequence 1 : Cohort 1
EXPERIMENTALEligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 2 : Cohort 1
EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 3 : Cohort 1
EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 4 : Cohort 1
EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 5 : Cohort 1
EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Subjects receiving treatment sequence 1 : Cohort 2
EXPERIMENTALEligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Subjects receiving treatment sequence 2 : Cohort 2
EXPERIMENTALEligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Subjects receiving treatment sequence 3 : Cohort 2
EXPERIMENTALEligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Subjects receiving treatment sequence 4 : Cohort 2
EXPERIMENTALEligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Subjects receiving treatment sequence 1 : Cohort 3
EXPERIMENTALEligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 2 : Cohort 3
EXPERIMENTALEligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Subjects receiving treatment sequence 3 : Cohort 3
EXPERIMENTALEligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Subjects receiving treatment sequence 4 : Cohort 3
EXPERIMENTALEligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Subjects receiving treatment sequence 5 : Cohort 3
EXPERIMENTALEligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
Interventions
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Subjects will receive placebo administered using DISKUS inhaler.
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Eligibility Criteria
You may qualify if:
- Body mass index within the range 18.5-29.9 (kg/m2)
- Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years.
- Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients):
- Subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 greater than 60% and less than 90% predicted.
- During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \> or equal to 12.0% over baseline and an absolute change of \> or equal to 300 mL within 30 minutes following 400 mcg salbutamol.
You may not qualify if:
- Any clinically relevant abnormality
- Subjects who have a screening haemoglobin values \< 11 g/dL
- The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days
- Subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Manchester, Lancashire, M23 9LT, United Kingdom
GSK Investigational Site
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2006
First Posted
August 15, 2006
Study Start
August 24, 2005
Primary Completion
July 6, 2006
Study Completion
July 6, 2006
Last Updated
September 29, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.