- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00887406
Study of GSK961081 in Healthy Volunteer Subjects
September 28, 2021 updated by: Theravance Biopharma
A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetic Profile and Pharmacodynamics of Single and Repeat Inhaled Doses of GSK961081 in Healthy Subjects
GSK961081 is a new long-acting bronchodilator being developed for the treatment of chronic obstructive pulmonary disease (COPD).
This study is the first clinical study in humans.
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK961081 in healthy male subjects.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy adult males aged between 18 and 50 years.
- Body mass index within the range 18.5-29.9 kilograms/meter2 (kg/m2).
- Forced Expiratory Volume in 1 second (FEV1) <80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio <0.7
- Response to Salbutamol defined as: an increase in sGAW of >15% over pre-dose baseline within 2 h following administration of 400 mcg Salbutamol by MDI inhaler OR: a documented increase in sGAW of >15% over pre-dose baseline within 2 h following administration of 400 mcg Salbutamol by MDI inhaler within 6 months of screening.
- Response to Ipratropium bromide defined as: an increase in sGaw of >25% over pre-dose baseline within 2 h following 80 mcg Ipratropium bromide; OR: a documented increase in sGaw of >25% over pre-dose baseline 2 h following administration of 80 mcg Ipratropium bromide within 6 months of screening.
- A signed and dated written informed consent is obtained for the subject
- The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
- Subjects who are 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 > or = 10 pack years.
[number of pack years = (number of cigarettes per day/20) x number of years smoked]
Exclusion Criteria:
- Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter).
- A history of breathing problems (i.e. history of asthmatic symptoms). Screening lung function tests (FEV1, FVC and sGaw) will be performed to confirm normal lung function parameters.
- A mean QTc(B) and QTc(F) value at screening >430msec, the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120-210msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- The subject has donated a unit of blood within the 90 days or intends to donate within 90 days after completing the study.
- A history of claustrophobia such that they may not tolerate plethysmography measurements.
- The subject is currently taking regular (or course of) medication whether prescribed or not, including vitamins and herbal remedies such as St John's Wort.
- The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (which ever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
- The subject has participated in a clinical study with another New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days.
- The subject is infected with the Hepatitis B, Hepatitis C, or HIV virus.
- The subject has a positive pre-study urine cotinine/ breath carbon monoxide test, urine drug/urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- A history of regular alcohol consumption exceeding weekly intake of alcohol greater than 28 units, or an average daily intake of greater than 4 units.
- Are unable to use the Prodose AAD nebuliser device correctly.
- An unwillingness of subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or tubal ligation if the woman could become pregnant from the time of the first dose study medication until 90 days post-dose.
- The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation.
- The subject has a history of hypersensitivity to Salbutamol or Ipratropium bromide, and for those subjects in cohorts III and IV, hypersensitivity to a beta-blocker.
- The subject has had a lower respiratory tract infection within 4 weeks of study start
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1, Period 2
GSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg
|
Single dose delivered via solution for nebulisation
Other Names:
single dose delivered via nebulsier
single dose delivered via solution for nebulisation
single dose via nebuliser
|
Experimental: Cohort 1, period 1
Placebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg
|
Single dose delivered via solution for nebulisation
Other Names:
single dose delivered via nebulsier
single dose delivered via solution for nebulisation
single dose via nebuliser
|
Experimental: Cohort 1, period 3
GSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg
|
Single dose delivered via solution for nebulisation
Other Names:
single dose delivered via nebulsier
single dose delivered via solution for nebulisation
single dose via nebuliser
|
Experimental: Cohort 1, period 4
GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo
|
Single dose delivered via solution for nebulisation
Other Names:
single dose delivered via nebulsier
single dose delivered via solution for nebulisation
single dose via nebuliser
|
Experimental: Cohort 2, period 1
Placebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg,
|
single dose via nebuliser
single dose delivered via solution for nebulisation
single dose via nebuliser
single dose via nebuliser
|
Experimental: Cohort 2, period 2
GSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg
|
single dose via nebuliser
single dose delivered via solution for nebulisation
single dose via nebuliser
single dose via nebuliser
|
Experimental: Cohort 2, period 3
GSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg
|
single dose via nebuliser
single dose delivered via solution for nebulisation
single dose via nebuliser
single dose via nebuliser
|
Experimental: Cohort 2, period 4
GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo
|
single dose via nebuliser
single dose delivered via solution for nebulisation
single dose via nebuliser
single dose via nebuliser
|
Experimental: Cohort 3
GSK961081 100mcg or Placebo
|
repeat dose via nebuliser
Other Names:
repeat dose via nebuliser
|
Experimental: Cohort 4
GSK961081 300mcg or Placebo
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repeat dose via nebuliser
repeat dose vai nebuliser
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
General safety and tolerability (adverse events, clinical laboratory safety tests, cardiac monitoring, vital signs (including postural changes in blood pressure), 12-lead ECG parameters including QTc(b) and QTc(f), blood glucose and serum potassium).
Time Frame: Pre and post-dose on Days 1, 4 and 7
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Pre and post-dose on Days 1, 4 and 7
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maxiumum and weighted mean (over 0-8 hours post-dose) for systolic and diastolic blood pressure, heart rate, QTc(F), QTc(B), plasma glucose and serum potassium
Time Frame: Days 1, 4 and 7
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Days 1, 4 and 7
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specific airway conductance (sGaW)
Time Frame: pre and post-dose on Days 1, 4 and 7
|
pre and post-dose on Days 1, 4 and 7
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forced expiratory volume in one second (FEV1)
Time Frame: Pre and post-dose on Days 1, 4 and 7
|
Pre and post-dose on Days 1, 4 and 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 7, 2005
Primary Completion (Actual)
October 4, 2006
Study Completion (Actual)
October 4, 2006
Study Registration Dates
First Submitted
April 23, 2009
First Submitted That Met QC Criteria
April 23, 2009
First Posted (Estimate)
April 24, 2009
Study Record Updates
Last Update Posted (Actual)
October 6, 2021
Last Update Submitted That Met QC Criteria
September 28, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104865
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
Study Data/Documents
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Individual Participant Data Set
Information identifier: 104865Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 104865Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 104865Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 104865Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 104865Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 104865Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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