Pulmonary Disease, Chronic ObstructivePhase 1NCT00803673
A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
A Phase 1 study testing 100mcg, 500mcg and 1000mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers 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?
- 100mcg, 500mcg and 1000mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- 5 May 2008to 16 Oct 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.
- Male or female 18 to 65 years of age inclusive.
- Non-childbearing women or women of child bearing potential who agree to use contraception
- Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:
- Part 1: may include extensive, intermediate and ultra-rapid metabolizers
- Part 2: includes only poor (no enzyme activity) metabolizers, with previously confirmed phenotype
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- Body Mass Index within the range 18 - 30 kg/m2 (inclusive).
- Capable of giving written informed consent
- Normal ECG;
- Normal lung function.
- 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
- 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).
- Abnormal ECG.
- Abnormal blood pressure.
- Abnormal heart rate
- The subject has a positive pre-study drug/alcohol screen.
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- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
- A positive test for HIV antibody (if determined by the local SOPs).
- History of high alcohol consumption within three months of the study
- The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the IP (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 e.g. paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication
- 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 500mL 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 milk protein or the excipients magnesium stearate and lactose monohydrate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomized, Double-blind, Dose Ascending, Placebo-controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects and in a Healthy Population of Cytochrome P450 Isoenzyme 2D6 Poor Metabolisers.
This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- 100mcg, 500mcg, 1000mcg, Placebo
- Keywords
- Healthy volunteers, New formulation
- 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.
100mcgDrug
100mcg '719
500mcgDrug
500mcg '719
1000mcgDrug
1000mcg '719
PlaceboDrug
Placebo '719
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 100mcg 719 Receives: Drug: 100mcg |
| Active 2 | Experimental | 500mcg '719 Receives: Drug: 500mcg |
| Active 3 | Experimental | 1000mcg '719 Receives: Drug: 1000mcg |
| Placebo | Placebo comparator | Placebo '719 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests
Measured: Various
Secondary outcomes (1)
Blood and urine levels of study drug
Measured: various
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study start5 May 2008
- Primary completion16 Oct 2008
- Study completion16 Oct 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
- 36 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
- NCT00803673
- Sponsor's protocol ID
- 110106
- Status last verified
- Jul 2017
- First submitted
- 4 Dec 2008
- Last updated
- 21 Jul 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
Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Investig. 2013 Sep;33(9):653-64. doi: 10.1007/s40261-013-0109-6.
PubMed 23881566
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Randomized, Double-blind, Dose Ascending, Placebo-controlled Study, in Two Parts, to Evaluate the Safety, Tolerability and Pharmacokinetics of Escalating Single and Repeat Inhaled Doses of GSK573719 and Placebo Formulated With the Excipient Magnesium Stearate, in Healthy Subjects and in a Healthy Population of Cytochrome P450 Isoenzyme 2D6 Poor Metabolisers.
- ClinicalTrials.gov ID
- NCT00803673
- Acronym / sponsor ID
- 110106
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Healthy volunteers, New formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 May 2008 (actual)
- Primary completion
- 16 Oct 2008 (actual)
- Study completion
- 16 Oct 2008 (actual)
- First posted
- 5 Dec 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.
This study is to look at a new formulation of GSK573719 to see if it is safe and tolerated in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: 100mcg100mcg 719 |
| Active 2 | Experimental | Drug: 500mcg500mcg '719 |
| Active 3 | Experimental | Drug: 1000mcg1000mcg '719 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo '719 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy.
- Male or female 18 to 65 years of age inclusive.
- Non-childbearing women or women of child bearing potential who agree to use contraception
- Subject has had their CYP2D6 genotype confirmed and can be included in either of the following parts:
- Part 1: may include extensive, intermediate and ultra-rapid metabolizers
Key exclusion criteria (18 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).
- Abnormal ECG.
- Abnormal blood pressure.
- Abnormal heart rate
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 |
|---|---|---|
| 100mcg100mcg '719 | Drug | Active |
| 500mcg500mcg '719 | Drug | Active 2 |
| 1000mcg1000mcg '719 | Drug | Active 3 |
| PlaceboPlacebo '719 | Drug | Placebo |
Primary outcome
General safety and tolerability endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests
Time frame: Various
1 secondary outcome
Blood and urine levels of study drug
Time frame: various
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 21 Jul 2017.
- Derived from this study: PubMed 23881566Cahn A, Mehta R, Preece A, Blowers J, Donald A. Safety, tolerability and pharmacokinetics and pharmacodynamics of inhaled once-daily umeclidinium in healthy adults deficient in CYP2D6 activity: a double-blind, randomized clinical trial. Clin Drug Investig. 2013 Sep;33(9):653-64. doi: 10.1007/s40261-013-0109-6.
- Results for study 110106 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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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 100mcg, 500mcg and 1000mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in Belgium.
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 14 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 21 Jul 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 Belgium. 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. Some participants in this study may receive a placebo. 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 endpoints: Adverse Events (AE), HR, BP, 12- lead ECG and lung function (FEV1) and clinical laboratory safety tests (time frame: Various). 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 NCT00803673, 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 21 Jul 2017.