Pulmonary Disease, Chronic ObstructivePhase 1NCT00687700

A Study to Investigate the Pharmacology of a Dual Pharmacophore in Healthy Volunteers

A Phase 1 study testing GSK961081 and Propranolol in people with Pulmonary Disease, Chronic Obstructive, run by Theravance Biopharma at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of GSK961081 and Propanolol is used to give a total effect of bronchodilation. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: GSK961081 and Propranolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Mar 2008to 27 May 2008
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult males aged between 18 and 50 years.
Body mass index within the range 19-29.9 kg/m2.
FEV1 ≥ 80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio ≥ 0.7
Signed and dated written informed consent is obtained from the subject
The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
The subject has an increase in sGAW of ≥15% over pre-dose baseline within 2 h of administration of 400 µg salbutamol by MDI inhaler at screening or in the 3 months before screening.
The subject has an increase in sGAW of ≥25% over pre-dose baseline within 2 h following 80 µg ipratropium bromide at screening or in the 3 months before screening.
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 ≥ 10 pack years.

Who cannot join

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 respiratory disease (i.e. history of asthmatic symptoms).
Clinically significant abnormal 12 lead ECG at
A subject in whom ipratropium bromide, salbutamol or propranolol are contraindicated.
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 45-90 beats per minute (bpm) at screening.

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The subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study.
The subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, 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 medical monitor the medication will not interfere with the study procedures or compromise subject safety.
The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months.
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
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 history of regular alcohol consumption exceeding weekly intake of alcohol greater than 28 units for males, or an average daily intake of greater than 4 units.
Are unable to use the inhaler correctly.
The subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation.
The subject has had a lower respiratory tract infection within 4 weeks of study start.
Subject is unable to perform the sGAW measurements

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Harrow, Middlesex, HA1 3UJ

Other trials in United Kingdom

About this study

Official title: A Study to Investigate the Relative Pharmacological Activity of Aninhaled B2-agonist/Anticholinergic Dual Pharmacophore Inhealthy Volunteers

Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of GSK961081 and Propanolol is used to give a total effect of bronchodilation.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: GSK961081, GSK961081 matching placebo, Propranolol, Propranolol matching placebo
Keywords: propranolol, B2-agonist,, B-antagonist,
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK961081Drug
GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning.
GSK961081 matching placeboDrug
GSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning.
PropranololDrug
Propranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water.
Propranolol matching placeboDrug
Propranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water.

Study groups in NCT00687700
Study group	Role	What they receive
All subjects	Experimental	Eligible subjects will receive GSK961081 (400 micrograms or 1200 micrograms), GSK961081 matching placebo, propranolol (80 milligrams) and propranolol matching placebo in five treatment sessions through ten different crossover treatment sequences. There will be a washout period between treatment sessions of 7 to 14 days. Receives: Drug: GSK961081; Drug: GSK961081 matching placebo; Drug: Propranolol; Drug: Propranolol matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the bronchodilation of single doses of GSK961081 over 24 hours following ß blockade with the ß antagonist propranolol as measured by sGaw in healthy subjects.
Measured: Up to 32 hours

Secondary outcomes (4)

Assess safety of GSK961081 after single doses of it with&without ß blockade with propranolol as measured by specific indicators
Measured: Up to 71 days
Adverse events, clinical laboratory safety tests, FEV1, vital signs, 12-lead ECG parameters, blood glucose and serum potassium.
Measured: Up to 71 days
Propranolol and GSK961081blood levels to derive pharmacokinetics
Measured: Up to 32 hours
Assess systemic pharmacokinetics of GSK961081 and propranolol after single doses of both
Measured: Up to 32 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 200827 May 2008

First posted2 Jun 2008 (estimated)
Study start10 Mar 2008
Primary completion27 May 2008
Study completion27 May 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00687700
Sponsor's protocol ID: MAB110553
Status last verified: Sep 2021
First submitted: 28 May 2008
Last updated: 6 Oct 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Investigate the Relative Pharmacological Activity of Aninhaled B2-agonist/Anticholinergic Dual Pharmacophore Inhealthy Volunteers
ClinicalTrials.gov ID: NCT00687700
Acronym / sponsor ID: MAB110553
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: propranolol, B2-agonist,, B-antagonist,
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Theravance BiopharmaIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 10 Mar 2008 (actual)
Primary completion: 27 May 2008 (actual)
Study completion: 27 May 2008 (actual)
First posted: 2 Jun 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of GSK961081 and Propanolol is used to give a total effect of bronchodilation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Number of arms: 1

Arm	Type	Receives
All subjects	Experimental	Drug: GSK961081, Drug: GSK961081 matching placebo, Drug: Propranolol, Drug: Propranolol matching placeboEligible subjects will receive GSK961081 (400 micrograms or 1200 micrograms), GSK961081 matching placebo, propranolol (80 milligrams) and propranolol matching placebo in five treatment sessions through ten different crossover treatment sequences. There will be a washout period between treatment sessions of 7 to 14 days.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy adult males aged between 18 and 50 years.
Body mass index within the range 19-29.9 kg/m2.
FEV1 ≥ 80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio ≥ 0.7
Signed and dated written informed consent is obtained from the subject
The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.

Key exclusion criteria (18 listed)

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 respiratory disease (i.e. history of asthmatic symptoms).
Clinically significant abnormal 12 lead ECG at
A subject in whom ipratropium bromide, salbutamol or propranolol are contraindicated.
A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK961081GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning.	Drug	All subjects
GSK961081 matching placeboGSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning.	Drug	All subjects
PropranololPropranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water.	Drug	All subjects
Propranolol matching placeboPropranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water.	Drug	All subjects

Primary outcome

To assess the bronchodilation of single doses of GSK961081 over 24 hours following ß blockade with the ß antagonist propranolol as measured by sGaw in healthy subjects.
Time frame: Up to 32 hours

4 secondary outcomes

Assess safety of GSK961081 after single doses of it with&without ß blockade with propranolol as measured by specific indicators
Time frame: Up to 71 days
Adverse events, clinical laboratory safety tests, FEV1, vital signs, 12-lead ECG parameters, blood glucose and serum potassium.
Time frame: Up to 71 days
Propranolol and GSK961081blood levels to derive pharmacokinetics
Time frame: Up to 32 hours
Assess systemic pharmacokinetics of GSK961081 and propranolol after single doses of both
Time frame: Up to 32 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
Results for study MAB110553 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK961081 and Propranolol in people with Pulmonary Disease, Chronic Obstructive, run by Theravance Biopharma at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the bronchodilation of single doses of GSK961081 over 24 hours following ß blockade with the ß antagonist propranolol as measured by sGaw in healthy subjects. (time frame: Up to 32 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00687700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.