Lung Injury, AcutePhase 1NCT01640990
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers
A Phase 1 study testing Saline, GW328267X (total dose of 12mcg) and GW328267X (total dose of 40mcg) in people with Lung Injury, Acute, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study is a single dose evaluation using an open label dose escalating design. Cohort1 will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg) and 10 mcg/h… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lung Injury, Acute
- What is being tested?
- Saline, GW328267X (total dose of 12mcg) and GW328267X (total dose of 40mcg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2011to 9 Dec 2011
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male, between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
- Body weight ≥ 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
- Heart rate within the range 50 - 85 bpm (inclusive) and blood pressure range between 115/60 - 140/90 mmHg (inclusive) at Screening and Day 1.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
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- Single QTcF < 450 msec.
- 24-hour Holter monitoring at screening within normal limits.
- Peripheral veins suitable for venous blood sampling and cannulation
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- Have history of any pre-existing cardiac arrhythmias (including sinus tachycardia, atrial fibrillation or flutter) or finding on baseline examination that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial or may interfere with interpretation of cardiovascular safety results during the conduct of the trial.
- Current or history of asthma (with the exception of a history of asthma in childhood only).
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- Urinary cotinine levels indicative of smoking or a history of regular use of tobacco nicotine-containing products within 6 months prior to screening.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (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, with the exception of simple analgesics but including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- 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 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Escalating Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Slow Intravenous Infusion of GW328267X in Healthy Volunteers
This study is a single dose evaluation using an open label dose escalating design. Cohort1 will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg). Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2 hours after cessation of the intravenous infusion. PK measurements and measurement of erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30 minute intervals during the infusion of GW328267X up to and including 1 hour after cessation of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be done.
Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1. It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort 2 will consist of 3 healthy male volunteers and the study procedures for this additional Cohort will be the same as that described for Cohort 1.
- Conditions
- Lung Injury, Acute
- Being tested
- Saline, GW328267X (total dose of 12mcg), GW328267X (total dose of 40mcg)
- Keywords
- Healthy male volunteers, intravenous infusion, GW328267X, dose escalation,
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
30mins run-in period
GW328267X (total dose of 12mcg)Drug
8 mcg/h for 1.5 hours (total dose of 12mcg)
GW328267X (total dose of 40mcg)Drug
10 mcg/h for 4 hours (total dose of 40 mcg)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg), and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg) Receives: Drug: Saline; Drug: GW328267X (total dose of 12mcg); Drug: GW328267X (total dose of 40mcg) |
| Cohort 2 | Experimental | Dose to be determined after analysis of Cohort 1 Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability including number of subjects with adverse events assessment
Measured: baseline, Day 1, Day 2 and Day 10
Safety and tolerability including change from baseline and number subjects with abnormal clinical safety laboratory data
Measured: baseline, Day 1, Day 2 and Day 10
Safety and tolerability, including change from baseline and number of subjects with abnormal ECG assessments
Measured: baseline, Day 1, Day 2 and Day 10
Safety and tolerability, including change from baseline and number of subjects with abnormal vital signs (blood pressure and heart rate) assessments
Measured: baseline, Day 1, Day 2 and Day 10
Secondary outcomes (4)
Heart rate changes from baseline during intravenous infusion of GW328267X
Measured: baseline, Day 1, Day 2 and Day 10
Platelet aggregation parameters
Measured: Pre-dose, Day 1 5.5 hr, Day 2
Erythropoietin levels
Measured: Screening, Pre-dose, Day 2, Follow Up
Levels of GW328267X in plasma
Measured: baseline, Day 1 and Day 2 (24hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study start22 Nov 2011
- Primary completion9 Dec 2011
- Study completion9 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Injury, AcuteStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 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
- NCT01640990
- Sponsor's protocol ID
- 115387
- Status last verified
- Jun 2017
- First submitted
- 12 Jul 2012
- Last updated
- 12 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Escalating Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Slow Intravenous Infusion of GW328267X in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01640990
- Acronym / sponsor ID
- 115387
- Conditions
- Lung Injury, Acute
- Keywords
- Healthy male volunteers, intravenous infusion, GW328267X, dose escalation,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2011 (actual)
- Primary completion
- 9 Dec 2011 (actual)
- Study completion
- 9 Dec 2011 (actual)
- First posted
- 16 Jul 2012 (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 a single dose evaluation using an open label dose escalating design. Cohort1 will consist of 3 healthy male volunteers. Each volunteer will receive a slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg) and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg). Subjects will have continuous cardiac monitoring throughout the dosing period and up to 2 hours after cessation of the intravenous infusion. PK measurements and measurement of erythropoietin and platelet activation will also be done. Samples for PK will be taken at 30 minute intervals during the infusion of GW328267X up to and including 1 hour after cessation of the intravenous infusion. Samples for erythropoietin and platelet aggregation will be done.
Cohort 2 is optional and may be carried out in the event that the dose of GW328267X given in Cohort 1 is both well tolerated and subjects do not meet the stopping criteria. The decision to proceed to Cohort 2 and the dose level will be made by the GSK Study Team and the Investigator based on safety, tolerability and preliminary PK/PD data obtained in Cohort 1. It is planned that the maximum total dose given to any subject will not exceed 150mcg. Cohort 2 will consist of 3 healthy male volunteers and the study procedures for this additional Cohort will be the same as that described for Cohort 1.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Saline, Drug: GW328267X (total dose of 12mcg), Drug: GW328267X (total dose of 40mcg)slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg), and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg) |
| Cohort 2 | Experimental | Drug: SalineDose to be determined after analysis of Cohort 1 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male, between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until the follow up visit.
- Body weight ≥ 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
- Heart rate within the range 50 - 85 bpm (inclusive) and blood pressure range between 115/60 - 140/90 mmHg (inclusive) at Screening and Day 1.
Key exclusion criteria (15 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- Have history of any pre-existing cardiac arrhythmias (including sinus tachycardia, atrial fibrillation or flutter) or finding on baseline examination that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in this trial or may interfere with interpretation of cardiovascular safety results during the conduct of the trial.
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 |
|---|---|---|
| Saline30mins run-in period | Drug | Cohort 1, Cohort 2 |
| GW328267X (total dose of 12mcg)8 mcg/h for 1.5 hours (total dose of 12mcg) | Drug | Cohort 1 |
| GW328267X (total dose of 40mcg)10 mcg/h for 4 hours (total dose of 40 mcg) | Drug | Cohort 1 |
Primary outcome
Safety and tolerability including number of subjects with adverse events assessment
Time frame: baseline, Day 1, Day 2 and Day 10
Safety and tolerability including change from baseline and number subjects with abnormal clinical safety laboratory data
Time frame: baseline, Day 1, Day 2 and Day 10
Safety and tolerability, including change from baseline and number of subjects with abnormal ECG assessments
Time frame: baseline, Day 1, Day 2 and Day 10
Safety and tolerability, including change from baseline and number of subjects with abnormal vital signs (blood pressure and heart rate) assessments
Time frame: baseline, Day 1, Day 2 and Day 10
4 secondary outcomes
Heart rate changes from baseline during intravenous infusion of GW328267X
Time frame: baseline, Day 1, Day 2 and Day 10
Platelet aggregation parameters
Time frame: Pre-dose, Day 1 5.5 hr, Day 2
Erythropoietin levels
Time frame: Screening, Pre-dose, Day 2, Follow Up
Levels of GW328267X in plasma
Time frame: baseline, Day 1 and Day 2 (24hrs)
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 12 Jun 2017.
- Results for study 115387 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 Saline, GW328267X (total dose of 12mcg) and GW328267X (total dose of 40mcg) in people with Lung Injury, Acute, 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 15 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 12 Jun 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 including number of subjects with adverse events assessment (time frame: baseline, Day 1, Day 2 and Day 10). The study lists 4 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 12 Jun 2017.