Pulmonary Disease, Chronic ObstructivePhase 1NCT00500461
Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
A Phase 1 study testing GSK233705 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK233705
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2007to 25 Jul 2007
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects;
- Between the ages of 18-55 years, inclusive
- Body mass index within the range 18.0 to 30.0 kg/m2.
- Non-smokers
- Adequate venous access for intermittent cannulation
- 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 in the following: at the screening medical assessment
- A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
- 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 of 40-90 bpm at screening.
- History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
- The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
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- The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
- The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
- The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
- The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open-label, Sequential Ascending Cross Over Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Ascending Single Doses, Nominally 10, 30, 70 and 110µg Intravenous Doses and a Single 250µg Oral Dose of GSK233705 in Healthy Volunteers.
GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK233705
- Keywords
- Muscarinic Receptor Antagonist,, intravenous infusion,, pharmacokinetics, healthy subjects,, safety,, tolerability,, Anticholinergic,, oral dosing,
- 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
GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving GSK233705 | Experimental | Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points. Receives: Drug: GSK233705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,
Measured: out to 8 hours post dose
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and
Measured: out to 24 hours
review of adverse events ongoing through out study.
Measured: through out study.
Secondary outcomes (1)
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.
Measured: out to 48 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study start4 Jun 2007
- Primary completion1 Jul 2007
- Study completion25 Jul 2007
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT00500461
- Sponsor's protocol ID
- AC2106213
- Status last verified
- Aug 2017
- First submitted
- 10 Jul 2007
- Last updated
- 7 Aug 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
This study has not been published in the scientific literature.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open-label, Sequential Ascending Cross Over Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Ascending Single Doses, Nominally 10, 30, 70 and 110µg Intravenous Doses and a Single 250µg Oral Dose of GSK233705 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT00500461
- Acronym / sponsor ID
- AC2106213
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Muscarinic Receptor Antagonist,, intravenous infusion,, pharmacokinetics, healthy subjects,, safety,, tolerability,, Anticholinergic,, oral dosing,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2007 (actual)
- Primary completion
- 1 Jul 2007 (actual)
- Study completion
- 25 Jul 2007 (actual)
- First posted
- 12 Jul 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.
GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving GSK233705 | Experimental | Drug: GSK233705Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy male subjects;
- Between the ages of 18-55 years, inclusive
- Body mass index within the range 18.0 to 30.0 kg/m2.
- Non-smokers
- Adequate venous access for intermittent cannulation
Key exclusion criteria (10 listed)
- Any clinically important abnormality identified in the following: at the screening medical assessment
- A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
- 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 of 40-90 bpm at screening.
- History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test 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 |
|---|---|---|
| GSK233705GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate. | Drug | Subjects receiving GSK233705 |
Primary outcome
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,
Time frame: out to 8 hours post dose
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and
Time frame: out to 24 hours
review of adverse events ongoing through out study.
Time frame: through out study.
1 secondary outcome
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.
Time frame: out to 48 hours post dose.
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 7 Aug 2017.
- BackgroundThis study has not been published in the scientific literature.
- Results for study AC2106213 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 GSK233705 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 8 inclusion and 10 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 7 Aug 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?
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose, (time frame: out to 8 hours post dose). The study lists 3 primary outcomes in all. 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 NCT00500461, 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 7 Aug 2017.