Pulmonary Disease, Chronic ObstructivePhase 1NCT00671216
A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy Subjects.
A Phase 1 study testing GSK233705, GW642444 and GSK233705 and GW642444 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary Disease. Development of these two inhaled drugs as a combination therapy would have potential for improved patient benefit as they both work through different mechanisms and the combined bronchodilatory effect might be additive. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK233705, GW642444 and GSK233705 and GW642444
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2008to 7 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age.
- Female subjects must be of non childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal
- Male subjects must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until 90 days post-last dose.
- BMI within the range 18 - 30 kg/m2 (inclusive).
- Average QTc(B)≤450 msec taken from triplicate assessments at screening.
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- No clinically active and relevant abnormality on 12-lead ECG at screening or 24h Holter ECG.
- Normal spirometry (FEV1 ≥ 80% of predicted, FEV1/FVC ≥ 70%).
- Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = (cigarettes per day smoked/20) x number of years smoked))
- A signed and dated written informed consent is obtained from the subject
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Available to complete the study
Who cannot join
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
- A history of breathing problems (i.e. history of asthmatic symptomatology, unless asthma in childhood that has now resolved and no longer requires maintenance therapy which should not be an exclusion).
- A mean QTc(B) value at screening >450msec, or an ECG that is not suitable for QT measurements (e.g. LBBB or poorly defined termination of the T wave).
- A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
- A mean heart rate outside the range 40-90 bpm at screening.
- The subject has a positive pre-study drug/alcohol screen. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
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- A positive test for HIV antibody (if determined by the local SOP's).
- History of high alcohol consumption within 3months of the study defined as:
- an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, (except for simple analgesics eg paracetamol), 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 (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products prior to screening.
- The subject is unable to use the novel dry powder inhaler correctly.
- The subject has a known allergy or hypersensitivity to ipratropium bromide, Tiotropium, atropine and any of its derivatives.
- Any adverse reaction including immediate or delayed hypersensitivity to any β2 agonist or sympathomimetic drug,
- The subject has a known allergy or hypersensitivity to milk protein or the excipients lactose monohydrate and MgSt.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705 and GW642444 as Monotherapies and in Combination in Healthy Subjects.
GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary Disease. Development of these two inhaled drugs as a combination therapy would have potential for improved patient benefit as they both work through different mechanisms and the combined bronchodilatory effect might be additive. This study will look at the this combination, for the first time, in healthy subjects.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK233705, GW642444, GSK233705 and GW642444, Placebo
- Keywords
- safety, pharmacodynamics, Muscarinic Receptor Antagonist, tolerability, healthy subjects, GS642444, GSK233705, Anticholinergic, ß2 agonist, pharmacokinetics
- 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.
GSK233705Drug
Subjects will receive 200 (mcg) microgram once daily as a single dose
GW642444Drug
Also called GSK233705
Subjects will receive 50 mcg once daily as a single dose
GSK233705 and GW642444Drug
Subjects will receive combination of GSK233705 200 mcg and GW642444 50 mcg as a single oral dose
PlaceboDrug
Placebo matching study medication will be inhaled by subjects
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | Subjects will receive first placebo, then GSK233705, GW642444 and combination of GSK233705 and GW642444 Receives: Drug: GSK233705; Drug: GW642444; Drug: GSK233705 and GW642444; Drug: Placebo |
| Period 2 | Experimental | Subjects will receive first combination of GSK233705 and GW642444, then placebo, GSK233705 and GW642444 Receives: Drug: GSK233705; Drug: GW642444; Drug: GSK233705 and GW642444; Drug: Placebo |
| Period 3 | Experimental | Subjects will receive first GSK233705, then GW642444, combination of GSK233705 and GW642444 and later placebo Receives: Drug: GSK233705; Drug: GW642444; Drug: GSK233705 and GW642444; Drug: Placebo |
| Period 4 | Experimental | Subjects will receive first GW642444, then combination of GSK233705 and GW642444, placebo, and later GSK233705 Receives: Drug: GSK233705; Drug: GW642444; Drug: GSK233705 and GW642444; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety endpoints: measured over 24 hours post dose for all 4 dose periods, heart rate, systolic and diastolic blood pressure, 12- lead ECG and lung function and clinical laboratory safety tests. Adverse events over whole study.
Measured: Up to Day 2
Secondary outcomes (1)
Blood levels of GW642444, Blood levels of GSK233705, Blood Levels of potassium
Measured: Pre-dose; Day 1- 5, 15 and 30 minutes, 1, 2, 4, 5,6, 8, 12, 16 and 24 hours and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study start20 May 2008
- Primary completion7 Jul 2008
- Study completion7 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671216
- Sponsor's protocol ID
- DB1111509
- Status last verified
- Oct 2017
- First submitted
- 30 Apr 2008
- Last updated
- 4 Oct 2017
- 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.
Publications
GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705 and GW642444 as Monotherapies and in Combination in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00671216
- Acronym / sponsor ID
- DB1111509
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- safety, pharmacodynamics, Muscarinic Receptor Antagonist, tolerability, healthy subjects, GS642444, GSK233705, Anticholinergic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 May 2008 (actual)
- Primary completion
- 7 Jul 2008 (actual)
- Study completion
- 7 Jul 2008 (actual)
- First posted
- 5 May 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.
GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary Disease. Development of these two inhaled drugs as a combination therapy would have potential for improved patient benefit as they both work through different mechanisms and the combined bronchodilatory effect might be additive. This study will look at the this combination, for the first time, in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: GSK233705, Drug: GW642444, Drug: GSK233705 and GW642444, Drug: PlaceboSubjects will receive first placebo, then GSK233705, GW642444 and combination of GSK233705 and GW642444 |
| Period 2 | Experimental | Drug: GSK233705, Drug: GW642444, Drug: GSK233705 and GW642444, Drug: PlaceboSubjects will receive first combination of GSK233705 and GW642444, then placebo, GSK233705 and GW642444 |
| Period 3 | Experimental | Drug: GSK233705, Drug: GW642444, Drug: GSK233705 and GW642444, Drug: PlaceboSubjects will receive first GSK233705, then GW642444, combination of GSK233705 and GW642444 and later placebo |
| Period 4 | Experimental | Drug: GSK233705, Drug: GW642444, Drug: GSK233705 and GW642444, Drug: PlaceboSubjects will receive first GW642444, then combination of GSK233705 and GW642444, placebo, and later GSK233705 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age.
- Female subjects must be of non childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal
- Male subjects must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication until 90 days post-last dose.
- BMI within the range 18 - 30 kg/m2 (inclusive).
Key exclusion criteria (20 listed)
- Any clinically important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead). 24hr Holter monitoring outside normal limits.
- A history of breathing problems (i.e. history of asthmatic symptomatology, unless asthma in childhood that has now resolved and no longer requires maintenance therapy which should not be an exclusion).
- A mean QTc(B) value at screening >450msec, or an ECG that is not suitable for QT measurements (e.g. LBBB or poorly defined termination of the T wave).
- A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
- A mean heart rate outside the range 40-90 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 |
|---|---|---|
| GSK233705Subjects will receive 200 (mcg) microgram once daily as a single dose | Drug | Period 1, Period 2, Period 3, Period 4 |
| GW642444Also: GSK233705Subjects will receive 50 mcg once daily as a single dose | Drug | Period 1, Period 2, Period 3, Period 4 |
| GSK233705 and GW642444Subjects will receive combination of GSK233705 200 mcg and GW642444 50 mcg as a single oral dose | Drug | Period 1, Period 2, Period 3, Period 4 |
| PlaceboPlacebo matching study medication will be inhaled by subjects | Drug | Period 1, Period 2, Period 3, Period 4 |
Primary outcome
General safety endpoints: measured over 24 hours post dose for all 4 dose periods, heart rate, systolic and diastolic blood pressure, 12- lead ECG and lung function and clinical laboratory safety tests. Adverse events over whole study.
Time frame: Up to Day 2
1 secondary outcome
Blood levels of GW642444, Blood levels of GSK233705, Blood Levels of potassium
Time frame: Pre-dose; Day 1- 5, 15 and 30 minutes, 1, 2, 4, 5,6, 8, 12, 16 and 24 hours and Day 2
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 4 Oct 2017.
- BackgroundGSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary.
- 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 DB1111509 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 GSK233705, GW642444 and GSK233705 and GW642444 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline 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 12 inclusion and 20 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 4 Oct 2017. 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 endpoints: measured over 24 hours post dose for all 4 dose periods, heart rate, systolic and diastolic blood pressure, 12- lead ECG and lung function and clinical laboratory safety tests. Adverse events over whole study. (time frame: Up to Day 2). 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 NCT00671216, which also lists 1 linked publication.
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 4 Oct 2017.