Pulmonary Disease, Chronic ObstructivePhase 1NCT00539825
Effect of GSK704838 In Healthy Volunteers
A Phase 1 study testing GSK704838 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily treatment of chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK704838
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Feb 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject
- Aged between 18-55 years inclusive.
- Non-smokers
- Normal spirometry
- 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.
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- Available to complete the study.
- The subject is =50kg with a body mass index within the range 19.0 to 29.9 kg/m2 inclusive.
- Response to ipratropium bromide
Who cannot join
- Any clinically relevant and important 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
- A mean QTc(B) value > 450ms, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210ms or an ECG that is not suitable for QT measurements at screening.
- 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 inclusive at screening.
- History of use of tobacco- or nicotine-containing products within 6 months of screening, and/or positive urine cotinine test results at screening.
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- Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period at screening.
- The subject is currently taking regular (or a course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort etc.
- The subject has taken:
- prescription medications for 14 days prior to first dose of study drug, or
- Over-the-counter (OTC) medications/preparations (including herbal remedies, etc.) excluding simple analgesics for 48 hours prior to first dose of study drug, unless it is judged by the Investigator not to compromise the subject's safety or influence the outcome of the study.
- The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior first dose of study drug.
- The subject has tested positive for hepatitis C antibody (third generation enzyme immunoassay), hepatitis B surface antigen or HIV antibodies (if tested according to site SOP's) at screening.
- The subject has tested positive for drugs-of-abuse at screening.
- The subject has tested positive for urine alcohol (including ethanol) at screening.
- The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
- The subject is unable to use the DISKUS™ and/or HandiHaler inhaler devices correctly at screening.
- The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
- The subject has a known allergy or hypersensitivity to magnesium stearate, milk protein or the excipient lactose monohydrate, iodine, ipratropium bromide, tiotropium bromide, atropine and/or any of its derivatives.
- The subject has a significant clinical history of prostatic hypertrophy or narrow angle glaucoma.
- The subject has received an allogeneic bone marrow transplant.
- The subject has claustrophobia that may be aggravated by entering the whole body plethysmography cabinet.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Harrow, Middlesex, HA1 3UJ
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Crossover, Dose Escalation Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK704838 and Tiotropium Bromide
GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily treatment of chronic obstructive pulmonary disease (COPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK704838
- Keywords
- Anticholinergic,, Plethysmography, Muscarinic Receptor Antagonist,, COPD,, FTIH,
- 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.
GSK704838Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.
Secondary outcomes (3)
- Plasma and urine concentrations of GSK704838 and derived pharmacokinetic parameters over 48h post-dose. - Serial sGaw, Raw and FEV1 measurements over 24h post-dose.
Serial specific airway conductance (sGaw), Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity measurements (FVC) over 24 hours post-dose of GSK704838 and tiotropium bromide.
Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 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.
- 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
- Enrolment
- 20 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
- NCT00539825
- Sponsor's protocol ID
- AC6108697
- Status last verified
- Oct 2016
- First submitted
- 4 Oct 2007
- Last updated
- 31 Oct 2016
- 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 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Crossover, Dose Escalation Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK704838 and Tiotropium Bromide
- ClinicalTrials.gov ID
- NCT00539825
- Acronym / sponsor ID
- AC6108697
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Anticholinergic,, Plethysmography, Muscarinic Receptor Antagonist,, COPD,, FTIH,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Oct 2007 (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.
GSK704838C is a potent, pan-active mAChR antagonist, which is being developed for once-daily treatment of chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male subject
- Aged between 18-55 years inclusive.
- Non-smokers
- Normal spirometry
- A signed and dated written informed consent is obtained from the subject.
Key exclusion criteria (22 listed)
- Any clinically relevant and important 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
- A mean QTc(B) value > 450ms, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210ms or an ECG that is not suitable for QT measurements at screening.
- 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 inclusive 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 |
|---|---|---|
| GSK704838 | Drug | – |
Primary outcome
adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.
3 secondary outcomes
- Plasma and urine concentrations of GSK704838 and derived pharmacokinetic parameters over 48h post-dose. - Serial sGaw, Raw and FEV1 measurements over 24h post-dose.
Serial specific airway conductance (sGaw), Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity measurements (FVC) over 24 hours post-dose of GSK704838 and tiotropium bromide.
Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide.
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 31 Oct 2016.
- 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 GSK704838 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 9 inclusion and 22 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 31 Oct 2016. 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?
adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.. 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 31 Oct 2016.