Pulmonary Disease, Chronic ObstructivePhase 1NCT00555022
Effect of GSK1160724 In Healthy Volunteers
A Phase 1 study testing GSK1160724 and Tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK1160724 and Tiotropium bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2007to 7 Apr 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects. Female subjects must be of non-child bearing potential.
- 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
Show all 9Show fewer
- Available to complete the study
- The subject is greater than or equal to 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
Show all 21Show fewer
- 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 GSK1160724 and Tiotropium Bromide
GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK1160724, Tiotropium bromide, Placebo
- Keywords
- Anticholinergic,, FTIH,, Muscarinic Receptor Antagonist,, Plethysmography, COPD,
- 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.
GSK1160724Drug
GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.
Tiotropium bromideDrug
Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.
PlaceboDrug
Subjects will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Eligible subjects will receive one of the following treatment in cohort I and cohort II in five different treatment periods; Placebo, GSK1160724 (10 micrograms, 50 micrograms or 125 micrograms) and tiotropium bromide Receives: Drug: GSK1160724; Drug: Tiotropium bromide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Measured: Up to Week 24
Number of subjects with abnormal values for blood pressure
Systolic and diastolic blood pressure will be measured in a semi-recumbent position after 5 minutes rest.
Measured: Up to Week 24
Number of subjects with abnormal values for heart rate
Heart rate will be measured in a semi-recumbent position after 5 minutes rest.
Measured: Up to Week 24
Number of subjects with abnormal electrocardiogram (ECG) findings
Triplicate 12-lead ECGs will be measured in a semi-recumbent position after 5 minutes rest at each time point using ECG machine.
Measured: Up to Week 24
Number of subjects with abnormal findings after holter monitoring
Holter monitoring will be conducted at 24 hour.
Measured: Up to 24 hour
Forced expiratory volume in 1 second (FEV1)
Lung function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second.
Measured: Up to Week 24
Forced vital capacity (FVC)
Lung function will be measured by FVC, defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Up to Week 24
Number of subjects having abnormal hematology laboratory parameters
Hematology parameters will be assessed as a measure of safety.
Measured: Up to Week 24
Number of subjects with abnormal clinical chemistry parameters
Clinical parameters will be assessed as a measure of safety.
Measured: Up to Week 24
Number of subjects with abnormal values for urinalysis
Urinalysis will be performed as a measure of safety.
Measured: Up to Week 24
Maximum value for resting heart rate over 0-4 hour
Maximum value for heart rate over 0-4 hour will be determined.
Measured: Up to 4 hours
Maximum value for resting blood pressure over 0-4 hour
Maximum value for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Measured: Up to 4 hours
Maximum value for resting ECG over 0-4 hour
Maximum value for resting ECG over 0-4 hour will be determined.
Measured: Up to 4 hours
Weighted mean of resting heart rate over 0-4 hour
Weighted mean for resting heart rate over 0-4 hour will be determined.
Measured: Up to 4 hours
Weighted mean of resting blood pressure over 0-4 hour
Weighted mean for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Measured: Up to 4 hours
Weighted mean of resting ECG over 0-4 hour
Weighted mean for resting resting ECG over 0-4 hour will be determined.
Measured: Up to 4 hours
Secondary outcomes (22)
Plasma concentrations of GSK1160724
Plasma samples will be collected at the indicated time points to measure the concentration of GSK1160724.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Plasma concentrations of GSK1762245
Plasma samples will be collected at the indicated time points to measure the concentration of the active metabolite GSK1762245.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Urine concentrations of GSK1160724
Urine samples will be collected at the indicated time points to measure the concentration of GSK1160724.
Measured: 0-2 hours, 2-8 hours, 8-12 hours and 12-24 hours
Urine concentrations of GSK1762245
Urine samples will be collected at the indicated time points to measure the concentration of the active metabolite GSK1762245.
Measured: 0-2 hours, 2-8 hours, 8-12 hours and 12-24 hours
Maximum observed concentration (Cmax) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Cmax of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Time to Cmax (Tmax) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Tmax of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Time to last observed plasma concentration (Tlast) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Tlast of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration (AUC [0-T]) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
AUC (0-T) of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Area under the plasma concentration time curve from time 0 to infinity (AUC [0-infinity]) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
AUC (0-infinity) of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
The terminal phase elimination rate constant (Lambda z) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Lambda z of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
The Terminal phase half life (T1/2) of GSK1160724
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
T1/2 of GSK1762245
Blood samples will be collected at the indicated time points for pharmacokinetic analysis.
Measured: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Serial specific airway conductance (sGaw) response over 24 hours post-dose of GSK1160724 and tiotropium bromide
The sGaw response will be assessed by whole body plethysmograph at the indicated timepoints.
Measured: Up to 24 hours
FEV1 over 24 hours post-dose of GSK1160724 and tiotropium bromide
The sGaw response will be assessed by whole body plethysmograph at the indicated timepoints.
Measured: Up to 24 hours
FVC over 24 hours post-dose of GSK1160724 and tiotropium bromide
The sGaw response will be assessed by whole body plethysmograph at the indicated timepoints.
Measured: Up to 24 hours
Serial sGaw measurements over 48 hours of GSK1160724 and tiotropium bromide
The sGaw is a measure of the change in specific airway conductance. It will be assessed by whole body plethysmograph at the indicated timepoints.
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study start12 Dec 2007
- Primary completion7 Apr 2008
- Study completion7 Apr 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
- Enrolment
- 21 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
- NCT00555022
- Sponsor's protocol ID
- AC5108696
- Status last verified
- Sep 2017
- First submitted
- 6 Nov 2007
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. 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 GSK1160724 and Tiotropium Bromide
- ClinicalTrials.gov ID
- NCT00555022
- Acronym / sponsor ID
- AC5108696
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Anticholinergic,, FTIH,, Muscarinic Receptor Antagonist,, Plethysmography, COPD,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2007 (actual)
- Primary completion
- 7 Apr 2008 (actual)
- Study completion
- 7 Apr 2008 (actual)
- First posted
- 7 Nov 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.
GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Drug: GSK1160724, Drug: Tiotropium bromide, Drug: PlaceboEligible subjects will receive one of the following treatment in cohort I and cohort II in five different treatment periods; Placebo, GSK1160724 (10 micrograms, 50 micrograms or 125 micrograms) and tiotropium bromide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female subjects. Female subjects must be of non-child bearing potential.
- 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 (21 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 |
|---|---|---|
| GSK1160724GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler. | Drug | All subjects |
| Tiotropium bromideTiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device. | Drug | All subjects |
| PlaceboSubjects will receive placebo. | Drug | All subjects |
Primary outcome
Number of subjects with adverse events (AEs)
Time frame: Up to Week 24
An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Number of subjects with abnormal values for blood pressure
Time frame: Up to Week 24
Systolic and diastolic blood pressure will be measured in a semi-recumbent position after 5 minutes rest.
Number of subjects with abnormal values for heart rate
Time frame: Up to Week 24
Heart rate will be measured in a semi-recumbent position after 5 minutes rest.
Number of subjects with abnormal electrocardiogram (ECG) findings
Time frame: Up to Week 24
Triplicate 12-lead ECGs will be measured in a semi-recumbent position after 5 minutes rest at each time point using ECG machine.
Number of subjects with abnormal findings after holter monitoring
Time frame: Up to 24 hour
Holter monitoring will be conducted at 24 hour.
Forced expiratory volume in 1 second (FEV1)
Time frame: Up to Week 24
Lung function will be measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second.
Forced vital capacity (FVC)
Time frame: Up to Week 24
Lung function will be measured by FVC, defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Number of subjects having abnormal hematology laboratory parameters
Time frame: Up to Week 24
Hematology parameters will be assessed as a measure of safety.
Number of subjects with abnormal clinical chemistry parameters
Time frame: Up to Week 24
Clinical parameters will be assessed as a measure of safety.
Number of subjects with abnormal values for urinalysis
Time frame: Up to Week 24
Urinalysis will be performed as a measure of safety.
Maximum value for resting heart rate over 0-4 hour
Time frame: Up to 4 hours
Maximum value for heart rate over 0-4 hour will be determined.
Maximum value for resting blood pressure over 0-4 hour
Time frame: Up to 4 hours
Maximum value for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Maximum value for resting ECG over 0-4 hour
Time frame: Up to 4 hours
Maximum value for resting ECG over 0-4 hour will be determined.
Weighted mean of resting heart rate over 0-4 hour
Time frame: Up to 4 hours
Weighted mean for resting heart rate over 0-4 hour will be determined.
Weighted mean of resting blood pressure over 0-4 hour
Time frame: Up to 4 hours
Weighted mean for resting systolic and diastolic blood pressure over 0-4 hour will be determined.
Weighted mean of resting ECG over 0-4 hour
Time frame: Up to 4 hours
Weighted mean for resting resting ECG over 0-4 hour will be determined.
22 secondary outcomes
Plasma concentrations of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Plasma concentrations of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Urine concentrations of GSK1160724
Time frame: 0-2 hours, 2-8 hours, 8-12 hours and 12-24 hours
Urine concentrations of GSK1762245
Time frame: 0-2 hours, 2-8 hours, 8-12 hours and 12-24 hours
Maximum observed concentration (Cmax) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Cmax of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Time to Cmax (Tmax) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Tmax of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Time to last observed plasma concentration (Tlast) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Tlast of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration (AUC [0-T]) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
AUC (0-T) of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Area under the plasma concentration time curve from time 0 to infinity (AUC [0-infinity]) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
AUC (0-infinity) of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
The terminal phase elimination rate constant (Lambda z) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Lambda z of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
The Terminal phase half life (T1/2) of GSK1160724
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
T1/2 of GSK1762245
Time frame: Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours.12 hours, 16 hours, 24 hours, 48 hours Post-dose
Serial specific airway conductance (sGaw) response over 24 hours post-dose of GSK1160724 and tiotropium bromide
Time frame: Up to 24 hours
FEV1 over 24 hours post-dose of GSK1160724 and tiotropium bromide
Time frame: Up to 24 hours
FVC over 24 hours post-dose of GSK1160724 and tiotropium bromide
Time frame: Up to 24 hours
Serial sGaw measurements over 48 hours of GSK1160724 and tiotropium bromide
Time frame: Up to 48 hours
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 8 Sep 2017.
- Results for study AC5108696 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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 GSK1160724 and Tiotropium bromide 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 21 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 8 Sep 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?
Number of subjects with adverse events (AEs) (time frame: Up to Week 24). The study lists 16 primary outcomes in all. 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 8 Sep 2017.