Pulmonary Disease, Chronic ObstructivePhase 1NCT00887406
Study of GSK961081 in Healthy Volunteer Subjects
A Phase 1 study testing GSK961081 15mcg SD, GSK961081 3mcg SD and GSK961081 50mcg SD in people with Pulmonary Disease, Chronic Obstructive, run by Theravance Biopharma at 1 site in United Kingdom.
Trial summary
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. 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 15mcg SD, GSK961081 3mcg SD and GSK961081 50mcg SD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2005to 4 Oct 2006
- 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 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
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- 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]
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 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK961081 15mcg SD, GSK961081 3mcg SD, GSK961081 50mcg SD, Placebo SD, GSK961081 100mcg SD
- Keywords
- first time in human study, COPD, long-acting bronchodilator
- 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.
GSK961081 15mcg SDDrug
Also called Placebo, GSK961081 200mcg SD, GSK961081 50mcg SD, GSK961081 300mcg SD
Single dose delivered via solution for nebulisation
GSK961081 3mcg SDDrug
single dose delivered via nebulsier
GSK961081 50mcg SDDrug
single dose delivered via solution for nebulisation
Placebo SDDrug
single dose via nebuliser
GSK961081 100mcg SDDrug
single dose delivered via solution for nebulisation
GSK961081 200mcg SDDrug
single dose via nebuliser
GSK961081 300mcg SDDrug
single dose via nebuliser
GSK961081 100mcg RDDrug
Also called GSK961081 100mcg SD
repeat dose via nebuliser
GSK961081 300mcg RDDrug
repeat dose vai nebuliser
Placebo RDDrug
repeat dose via nebuliser
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Period 2 | Experimental | GSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg Receives: Drug: GSK961081 15mcg SD; Drug: GSK961081 3mcg SD; Drug: GSK961081 50mcg SD; Drug: Placebo SD |
| Cohort 1, period 1 | Experimental | Placebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg Receives: Drug: GSK961081 15mcg SD; Drug: GSK961081 3mcg SD; Drug: GSK961081 50mcg SD; Drug: Placebo SD |
| Cohort 1, period 3 | Experimental | GSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg Receives: Drug: GSK961081 15mcg SD; Drug: GSK961081 3mcg SD; Drug: GSK961081 50mcg SD; Drug: Placebo SD |
| Cohort 1, period 4 | Experimental | GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo Receives: Drug: GSK961081 15mcg SD; Drug: GSK961081 3mcg SD; Drug: GSK961081 50mcg SD; Drug: Placebo SD |
| Cohort 2, period 1 | Experimental | Placebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Receives: Drug: Placebo SD; Drug: GSK961081 100mcg SD; Drug: GSK961081 200mcg SD; Drug: GSK961081 300mcg SD |
| Cohort 2, period 2 | Experimental | GSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg Receives: Drug: Placebo SD; Drug: GSK961081 100mcg SD; Drug: GSK961081 200mcg SD; Drug: GSK961081 300mcg SD |
| Cohort 2, period 3 | Experimental | GSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg Receives: Drug: Placebo SD; Drug: GSK961081 100mcg SD; Drug: GSK961081 200mcg SD; Drug: GSK961081 300mcg SD |
| Cohort 2, period 4 | Experimental | GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo Receives: Drug: Placebo SD; Drug: GSK961081 100mcg SD; Drug: GSK961081 200mcg SD; Drug: GSK961081 300mcg SD |
| Cohort 3 | Experimental | GSK961081 100mcg or Placebo Receives: Drug: GSK961081 100mcg RD; Drug: Placebo RD |
| Cohort 4 | Experimental | GSK961081 300mcg or Placebo Receives: Drug: GSK961081 300mcg RD; Drug: Placebo RD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre and post-dose on Days 1, 4 and 7
Secondary outcomes (3)
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
Measured: Days 1, 4 and 7
specific airway conductance (sGaW)
Measured: pre and post-dose on Days 1, 4 and 7
forced expiratory volume in one second (FEV1)
Measured: Pre and post-dose on Days 1, 4 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study start7 Nov 2005
- Primary completion4 Oct 2006
- Study completion4 Oct 2006
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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887406
- Sponsor's protocol ID
- 104865
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2009
- 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.
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 Evaluate the Safety, Tolerability, Systemic Pharmacokinetic Profile and Pharmacodynamics of Single and Repeat Inhaled Doses of GSK961081 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00887406
- Acronym / sponsor ID
- 104865
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- first time in human study, COPD, long-acting bronchodilator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Nov 2005 (actual)
- Primary completion
- 4 Oct 2006 (actual)
- Study completion
- 4 Oct 2006 (actual)
- First posted
- 24 Apr 2009 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Period 2 | Experimental | Drug: GSK961081 15mcg SD, Drug: GSK961081 3mcg SD, Drug: GSK961081 50mcg SD, Drug: Placebo SDGSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg |
| Cohort 1, period 1 | Experimental | Drug: GSK961081 15mcg SD, Drug: GSK961081 3mcg SD, Drug: GSK961081 50mcg SD, Drug: Placebo SDPlacebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg |
| Cohort 1, period 3 | Experimental | Drug: GSK961081 15mcg SD, Drug: GSK961081 3mcg SD, Drug: GSK961081 50mcg SD, Drug: Placebo SDGSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg |
| Cohort 1, period 4 | Experimental | Drug: GSK961081 15mcg SD, Drug: GSK961081 3mcg SD, Drug: GSK961081 50mcg SD, Drug: Placebo SDGSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo |
| Cohort 2, period 1 | Experimental | Drug: Placebo SD, Drug: GSK961081 100mcg SD, Drug: GSK961081 200mcg SD, Drug: GSK961081 300mcg SDPlacebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, |
| Cohort 2, period 2 | Experimental | Drug: Placebo SD, Drug: GSK961081 100mcg SD, Drug: GSK961081 200mcg SD, Drug: GSK961081 300mcg SDGSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg |
| Cohort 2, period 3 | Experimental | Drug: Placebo SD, Drug: GSK961081 100mcg SD, Drug: GSK961081 200mcg SD, Drug: GSK961081 300mcg SDGSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg |
| Cohort 2, period 4 | Experimental | Drug: Placebo SD, Drug: GSK961081 100mcg SD, Drug: GSK961081 200mcg SD, Drug: GSK961081 300mcg SDGSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo |
| Cohort 3 | Experimental | Drug: GSK961081 100mcg RD, Drug: Placebo RDGSK961081 100mcg or Placebo |
| Cohort 4 | Experimental | Drug: GSK961081 300mcg RD, Drug: Placebo RDGSK961081 300mcg or Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
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 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.
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 |
|---|---|---|
| GSK961081 15mcg SDAlso: Placebo, GSK961081 200mcg SD, GSK961081 50mcg SD, GSK961081 300mcg SDSingle dose delivered via solution for nebulisation | Drug | Cohort 1, Period 2, Cohort 1, period 1, Cohort 1, period 3, Cohort 1, period 4 |
| GSK961081 3mcg SDsingle dose delivered via nebulsier | Drug | Cohort 1, Period 2, Cohort 1, period 1, Cohort 1, period 3, Cohort 1, period 4 |
| GSK961081 50mcg SDsingle dose delivered via solution for nebulisation | Drug | Cohort 1, Period 2, Cohort 1, period 1, Cohort 1, period 3, Cohort 1, period 4 |
| Placebo SDsingle dose via nebuliser | Drug | Cohort 1, Period 2, Cohort 1, period 1, Cohort 1, period 3, Cohort 1, period 4, Cohort 2, period 1, Cohort 2, period 2, Cohort 2, period 3, Cohort 2, period 4 |
| GSK961081 100mcg SDsingle dose delivered via solution for nebulisation | Drug | Cohort 2, period 1, Cohort 2, period 2, Cohort 2, period 3, Cohort 2, period 4 |
| GSK961081 200mcg SDsingle dose via nebuliser | Drug | Cohort 2, period 1, Cohort 2, period 2, Cohort 2, period 3, Cohort 2, period 4 |
| GSK961081 300mcg SDsingle dose via nebuliser | Drug | Cohort 2, period 1, Cohort 2, period 2, Cohort 2, period 3, Cohort 2, period 4 |
| GSK961081 100mcg RDAlso: GSK961081 100mcg SDrepeat dose via nebuliser | Drug | Cohort 3 |
| GSK961081 300mcg RDrepeat dose vai nebuliser | Drug | Cohort 4 |
| Placebo RDrepeat dose via nebuliser | Drug | Cohort 3, Cohort 4 |
Primary outcome
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
3 secondary outcomes
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
specific airway conductance (sGaW)
Time frame: pre and post-dose on Days 1, 4 and 7
forced expiratory volume in one second (FEV1)
Time frame: Pre and post-dose on Days 1, 4 and 7
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.
- 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.
- Results for study 104865 can be found on the GSK Clinical Study Register.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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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 15mcg SD, GSK961081 3mcg SD and GSK961081 50mcg SD 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 9 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.