Pulmonary Disease, Chronic ObstructivePhase 1NCT00599612
To Assess the Excretion Balance and Pharmacokinetics of a Single Oral Dose of [14C]GW856553 in Healthy Adult Males
A Phase 1 study testing GW856553 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This will be an open label study conducted at one site. Six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single 10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GW856553
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2008to 18 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 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged between 30 and 60 years inclusive, at the time of screening.
- Body weight >/ 50 kilogram (kg).
- A body mass index (BMI) within the range of 18.5 to 29.9 kg/ meter square (m^2) inclusive.
- Signed and dated written informed consent prior to admission to the study.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12-lead).
- Significant cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial.
- QT interval corrected by Bazett's Formula (QTcB) > 450 milliseconds (msecs)
- A definite or suspected personal or family history of adverse reactions or hypersensitivity to the trial drug or to drugs with a similar chemical structure.
- History of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units). One unit is equivalent to a half-pint [284 milliliter (mL)] of beer/lager; 25mL measure of spirits or 125mL of wine).
- Subjects with a history or presence of gastro-intestinal or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
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- Subjects who have consumed grapefruit or grapefruit juice within seven days of the first study day.
- Subjects who have had exposure to more than three new chemical entities within 12 months prior to the first dosing period.
- Subjects who have participated in a trial with a different new chemical entity within 90 days prior to the start of this study.
- If participation in the study will result in the volunteer having donated more than 400mL of blood in the previous 56 days.
- Subjects who have received a total body radiation dose of greater than 5.0 mSv (upper limit of WHO category II) or exposure to significant radiation (e.g. serial X-ray or CT scans, barium meal etc) in the 12 months prior to this study.
- History of elevated blood pressure or blood pressure persistently >140/90 mmHg at screening.
- An unwillingness to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, sub dermal implants or a tubal ligation if the women could become pregnant from the time of the first dose of the study medication until completion of the follow-up procedures.
- Lack of suitability for participation in this study, for any reason, in the opinion of the investigator.
- Any condition that could interfere with the accurate assessment and recovery of 14C.
- Prescribed or over-the-counter medication within 5 days (or 5 half lives, whichever is longer) prior to the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
- Liver function tests (ALT, AST, ALP, Gamma GT and bilirubin) > upper limit of normal (ULN) at screening
- Positive urine drug screen
- Positive HIV, Hepatitis B or C result at screening.
- History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive urine cotinine screen (urine cotinine > 250ng/ml).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Determine the Safety, Tolerability, Excretion Balance and Pharmacokinetics of [14C]GW856553, Administered as a Single Dose of an Oral Solution to Healthy Adult Male Subjects
This will be an open label study conducted at one site. Six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single 10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine and fecal samples will be collected until 216 hour after dosing but subjects may be discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted in a 24 hour period. Blood and plasma will be collected at various sample times after dosing to measure parent drug and total drug-related material. Samples of urine, faeces and plasma will be transferred into a separate study to characterize and quantify metabolites in these matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram (ECG) and clinical laboratory tests.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GW856553
- Keywords
- GW856553,, radiolabel, ADME,
- 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.
GW856553Drug
A dose of 10mg GW856553 containing 50µCi of [14C]GW856553 will be delivered as 100mL of a 0.1mg/mL GW856553/0.5 µCi/mL oral solution.
| Study group | Role | What they receive |
|---|---|---|
| Healthy male volunteers | Experimental | Six healthy male volunteers aged between 30-60 years old will be recruited for this study, Receives: Drug: GW856553 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the total radioactive dose administered over time
The urinary and fecal cumulative excretion will be analyzed.
Measured: Up to 10 days
Secondary outcomes (23)
Area under the concentration time curve (AUC) from time zero to infinity (AUC[0-inf]) of total drug
Blood samples will be collected at specific time points for calculating AUC (0-inf)
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Maximum plasma concentration(Cmax) of total drug
Blood samples will be collected at specific time points for calculating Cmax
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
AUC from zero to the time of the last measurable concentration (AUC[0-t]) of total drug
Blood samples will be collected at specific time points for calculating AUC(0-t)
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
First time of occurrence of maximum observed concentration (Tmax) of total drug
Blood samples will be collected at specific time points for calculating Tmax
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Terminal plasma half-life (t1/2) of total drug
Blood samples will be collected at specific time points for calculating T1/2
Measured: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
AUC(0-inf) of GW856553
Blood samples will be collected at specific time points for calculating AUC(0-inf)
Measured: Pre-dose and 1, 4, 12 hours post-dose
AUC(0-inf) of GSK198602
Blood samples for metabolite analysis will be collected at specific time points for calculating AUC(0-inf)
Measured: Pre-dose and 1, 4, 12 hours post-dose
Cmax of GW856553
Blood samples will be collected at specific time points for calculating Cmax
Measured: Pre-dose and 1, 4, 12 hours post-dose
Cmax of GSK198602
Blood samples for metabolite analysis will be collected at specific time points for calculating Cmax
Measured: Pre-dose and 1, 4, 12 hours post-dose
AUC(0-t) of GW856553
Blood samples will be collected at specific time points for calculating AUC(0-t)
Measured: Pre-dose and 1, 4, 12 hours post-dose
AUC(0-t) of GSK198602
Blood samples for metabolite analysis will be collected at specific time points for calculating AUC(0-t)
Measured: Pre-dose and 1, 4, 12 hours post-dose
Tmax of GW856553
Blood samples will be collected at specific time points for calculating Tmax
Measured: Pre-dose and 1, 4, 12 hours post-dose
Tmax of GSK198602
Blood samples for metabolite analysis will be collected at specific time points for calculating Tmax
Measured: Pre-dose and 1, 4, 12 hours post-dose
T1/2 of GW856553
Blood samples will be collected at specific time points for calculating T1/2
Measured: Pre-dose and 1, 4, 12 hours post-dose
T1/2 of GSK198602
Blood samples for metabolite analysis will be collected at specific time points for calculating T1/2
Measured: Pre-dose and 1, 4, 12 hours post-dose
Number of subjects with Adverse events (AEs) and serious adverse events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Measured: Up to 15 days
Number of subjects with abnormal ECG findings
Full 12-lead ECGs will be recorded using an ECG machine
Measured: Up to 15 days
Number of subjects with abnormal blood pressure values
Systolic and diastolic blood pressure values will be measured in a supine position having rested in this position for at least 10 minutes before each reading.
Measured: Up to 15 days
Number of subjects with abnormal heart rate values
Heart rate values will be measured in a supine position having rested in this position for at least 10 minutes before each reading.
Measured: Up to 15 days
Number of subjects with abnormal clinical chemistry parameters
Samples for clinical chemistry tests will be collected as a measure of safety
Measured: Up to 15 days
Number of subjects with abnormal clinical hematology parameters
Samples for clinical hematology tests will be collected as a measure of safety
Measured: Up to 15 days
Number of subjects with abnormal urine analysis parameters
Urine samples for urine analysis tests will be collected as a measure of safety
Measured: Up to 15 days
Number of subjects with abnormal liver function tests
Samples for liver function tests will be collected as a measure of safety
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study start17 Jan 2008
- Primary completion18 Feb 2008
- Study completion18 Feb 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT00599612
- Sponsor's protocol ID
- 107806
- Status last verified
- Aug 2017
- First submitted
- 11 Jan 2008
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Determine the Safety, Tolerability, Excretion Balance and Pharmacokinetics of [14C]GW856553, Administered as a Single Dose of an Oral Solution to Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT00599612
- Acronym / sponsor ID
- 107806
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GW856553,, radiolabel, ADME,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2008 (actual)
- Primary completion
- 18 Feb 2008 (actual)
- Study completion
- 18 Feb 2008 (actual)
- First posted
- 24 Jan 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 will be an open label study conducted at one site. Six healthy male subjects will be enrolled to ensure at least four fully evaluable subjects. Each subject will receive a single 10 milligram (mg) oral dose of GW856553 containing 50 microCi (µCi) of [14C] GW856553. Urine and fecal samples will be collected until 216 hour after dosing but subjects may be discharged after 168 hour if 90% of the dose is recovered and/or <1% of the dose is excreted in a 24 hour period. Blood and plasma will be collected at various sample times after dosing to measure parent drug and total drug-related material. Samples of urine, faeces and plasma will be transferred into a separate study to characterize and quantify metabolites in these matrices. Safety will be assessed by adverse event monitoring, vital signs, electrocardiogram (ECG) and clinical laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy male volunteers | Experimental | Drug: GW856553Six healthy male volunteers aged between 30-60 years old will be recruited for this study, |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male aged between 30 and 60 years inclusive, at the time of screening.
- Body weight >/ 50 kilogram (kg).
- A body mass index (BMI) within the range of 18.5 to 29.9 kg/ meter square (m^2) inclusive.
- Signed and dated written informed consent prior to admission to the study.
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Key exclusion criteria (20 listed)
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12-lead).
- Significant cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial.
- QT interval corrected by Bazett's Formula (QTcB) > 450 milliseconds (msecs)
- A definite or suspected personal or family history of adverse reactions or hypersensitivity to the trial drug or to drugs with a similar chemical structure.
- History of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units). One unit is equivalent to a half-pint [284 milliliter (mL)] of beer/lager; 25mL measure of spirits or 125mL of wine).
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 |
|---|---|---|
| GW856553A dose of 10mg GW856553 containing 50µCi of [14C]GW856553 will be delivered as 100mL of a 0.1mg/mL GW856553/0.5 µCi/mL oral solution. | Drug | Healthy male volunteers |
Primary outcome
Percentage of the total radioactive dose administered over time
Time frame: Up to 10 days
The urinary and fecal cumulative excretion will be analyzed.
23 secondary outcomes
Area under the concentration time curve (AUC) from time zero to infinity (AUC[0-inf]) of total drug
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Maximum plasma concentration(Cmax) of total drug
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
AUC from zero to the time of the last measurable concentration (AUC[0-t]) of total drug
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
First time of occurrence of maximum observed concentration (Tmax) of total drug
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
Terminal plasma half-life (t1/2) of total drug
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168 hours post-dose
AUC(0-inf) of GW856553
Time frame: Pre-dose and 1, 4, 12 hours post-dose
AUC(0-inf) of GSK198602
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Cmax of GW856553
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Cmax of GSK198602
Time frame: Pre-dose and 1, 4, 12 hours post-dose
AUC(0-t) of GW856553
Time frame: Pre-dose and 1, 4, 12 hours post-dose
AUC(0-t) of GSK198602
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Tmax of GW856553
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Tmax of GSK198602
Time frame: Pre-dose and 1, 4, 12 hours post-dose
T1/2 of GW856553
Time frame: Pre-dose and 1, 4, 12 hours post-dose
T1/2 of GSK198602
Time frame: Pre-dose and 1, 4, 12 hours post-dose
Number of subjects with Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 15 days
Number of subjects with abnormal ECG findings
Time frame: Up to 15 days
Number of subjects with abnormal blood pressure values
Time frame: Up to 15 days
Number of subjects with abnormal heart rate values
Time frame: Up to 15 days
Number of subjects with abnormal clinical chemistry parameters
Time frame: Up to 15 days
Number of subjects with abnormal clinical hematology parameters
Time frame: Up to 15 days
Number of subjects with abnormal urine analysis parameters
Time frame: Up to 15 days
Number of subjects with abnormal liver function tests
Time frame: Up to 15 days
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 Aug 2017.
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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 GW856553 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 5 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 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?
Percentage of the total radioactive dose administered over time (time frame: Up to 10 days). 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 4 Aug 2017.