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GSK159802 In Healthy Male Subjects And Asthmatics

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
GSK159802
Placebo
Salmeterol
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion criteria: 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 a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease 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. Exclusion criteria: 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Subjects receiving treatment sequence 1 : Cohort 1

Subjects receiving treatment sequence 2 : Cohort 1

Subjects receiving treatment sequence 3 : Cohort 1

Subjects receiving treatment sequence 4 : Cohort 1

Subjects receiving treatment sequence 5 : Cohort 1

Subjects receiving treatment sequence 1 : Cohort 2

Subjects receiving treatment sequence 2 : Cohort 2

Subjects receiving treatment sequence 3 : Cohort 2

Subjects receiving treatment sequence 4 : Cohort 2

Subjects receiving treatment sequence 1 : Cohort 3

Subjects receiving treatment sequence 2 : Cohort 3

Subjects receiving treatment sequence 3 : Cohort 3

Subjects receiving treatment sequence 4 : Cohort 3

Subjects receiving treatment sequence 5 : Cohort 3

Arm Description

Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.

Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.

Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.

Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.

Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.

Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).

Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.

Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.

Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.

Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.

Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.

Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.

Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.

Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.

Outcomes

Primary Outcome Measures

Safety & tolerability of single inhaled doses of GSK159802.

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2006
Last Updated
September 27, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00364273
Brief Title
GSK159802 In Healthy Male Subjects And Asthmatics
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2005 (Actual)
Primary Completion Date
July 6, 2006 (Actual)
Study Completion Date
July 6, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving treatment sequence 1 : Cohort 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Arm Title
Subjects receiving treatment sequence 2 : Cohort 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Arm Title
Subjects receiving treatment sequence 3 : Cohort 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Arm Title
Subjects receiving treatment sequence 4 : Cohort 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Arm Title
Subjects receiving treatment sequence 5 : Cohort 1
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Arm Title
Subjects receiving treatment sequence 1 : Cohort 2
Arm Type
Experimental
Arm Description
Eligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Arm Title
Subjects receiving treatment sequence 2 : Cohort 2
Arm Type
Experimental
Arm Description
Eligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Arm Title
Subjects receiving treatment sequence 3 : Cohort 2
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Arm Title
Subjects receiving treatment sequence 4 : Cohort 2
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Arm Title
Subjects receiving treatment sequence 1 : Cohort 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Arm Title
Subjects receiving treatment sequence 2 : Cohort 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Arm Title
Subjects receiving treatment sequence 3 : Cohort 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Arm Title
Subjects receiving treatment sequence 4 : Cohort 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Arm Title
Subjects receiving treatment sequence 5 : Cohort 3
Arm Type
Experimental
Arm Description
Eligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.
Intervention Type
Drug
Intervention Name(s)
GSK159802
Intervention Description
GSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo administered using DISKUS inhaler.
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Intervention Description
Salmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
Primary Outcome Measure Information:
Title
Safety & tolerability of single inhaled doses of GSK159802.
Time Frame
Up to 71 days
Secondary Outcome Measure Information:
Title
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
Time Frame
Up to 71 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: 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 a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2F104300
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

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GSK159802 In Healthy Male Subjects And Asthmatics

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