AsthmaPhase 1NCT01086462
Intravenous Microdose Pharmacokinetic (PK) Study With [14C]-GSK2239633
A Phase 1 study testing GSK2239633 in people with Asthma, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
This study is a first administration to man microdose study to describe the pharmacokinetics of GSK2239633. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- GSK2239633
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jan 2010to 22 Feb 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects are defined as individuals who in the opinion of the Investigator are free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine, neurological and psychiatric disease or malignancy as determined by medical history, physical examination, laboratory studies, and other tests (including ECG). Subjects with values outside the normal range which are deemed to be clinically relevant should always be excluded from enrollment.
- Male between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- Subject must agree to use one of the contraception methods listed in Section 8.1. of the protocol. This criterion must be followed from the time of screening until 90 days after the follow up
- Body weight >or= 50 kg and BMI within range 18.5-29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Single QTcF <450 msec; or QTcF <480 msec in subjects with Bundle Branch Block
- Lifelong non-smokers or ex-smokers of greater than 6 months and <5 pack year history. Pack years = (cigarettes per day smoked/20) x number of years smoked.
- AST, ALT, alkaline phosphatase and bilirubin <or=1.5 ULN (isolated bilirubin >1.5 x ULN acceptable if bilirubin is fractionated and direct bilirubin <35%)
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of study defined as an average weekly intake of >12 units/week for males. One unit is equivalent to 8g of alcohol; a half-pint (~250ml) of beer, 1 glass (100ml) of wine or 1 (35 ml) measure of spirits.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (including snuff, nicotine-containing gum) within 6 months prior to screening
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- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to first dosing: 60 days, 5 half-lives or twice the duration of the biological effect of investigational product (whichever is longer)
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Participation in a clinical trial involving administration of 14C-labelled compounds within last 12 months
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with 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 procedures outlined in the protocol
- Subject is mentally or legally incapacitated
- A calculated creatinine clearance (Cockroft and Gault formula) of <90 mL/min
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Microdose Study to Describe the Intravenous Pharmacokinetics of [14C]-GSK2239633 in Healthy Male Subjects
This study is a first administration to man microdose study to describe the pharmacokinetics of GSK2239633.
Read the detailed description
The different shapes of the pharmacokinetic (PK) profiles following administration of GSK2239633 in rat and dog make it difficult to reliably predict the human PK profile. This microdose study will provide an early readout on the distribution and clearance profile of the drug in man and will be used to model potential clinical oral doses. The study will be conducted using an open-label, single dose design in one group of healthy male volunteers. Each subject will receive a single intravenous infusion of 100ug GSK2239633 (containing approximately 10kBq of [14C]-GSK2239633), administered over 15 minutes. Subjects will attend for a screening visit within 30 days prior to Day 1 and receive a single dose infusion of study drug on Day 1. Blood and urine samples will be taken over 48 hours for pharmacokinetic and total radioactivity analysis, and safety and tolerability will be monitored. Subjects will be discharged on Day 3 and a follow-up telephone call will be made 4-10 days post-dose.
- Conditions
- Asthma
- Being tested
- GSK2239633
- Keywords
- GSK2239633, RADIOLABEL, PHARMACOKINETICS, INTRAVENOUS, MICRODOSE
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2239633Drug
100 ug GSK2239633 containing approximately 10kBq [14C]-GSK2239633
| Study group | Role | What they receive |
|---|---|---|
| GSK2239633 | Experimental | Single dose infusion of study drug over 15 minutes Receives: Drug: GSK2239633 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (AUC0-inf, Cmax, AUC0-t, t1/2, clearance, volume of distribution) of [14C]-GSK2239633 and total drug-related material
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study start21 Jan 2010
- Primary completion22 Feb 2010
- Study completion22 Feb 2010
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 AsthmaStudies 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
- Not applicable
- 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
- NCT01086462
- Sponsor's protocol ID
- 114041
- Status last verified
- Jul 2017
- First submitted
- 18 Feb 2010
- Last updated
- 18 Jul 2017
- Results posted
- 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
Cahn A, Hodgson S, Wilson R, Robertson J, Watson J, Beerahee M, Hughes SC, Young G, Graves R, Hall D, van Marle S, Solari R. Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633, a CC-chemokine receptor 4 antagonist, in healthy male subjects: results from an open-label and from a randomised study. BMC Pharmacol Toxicol. 2013 Feb 28;14:14. doi: 10.1186/2050-6511-14-14.
PubMed 23448278
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Microdose Study to Describe the Intravenous Pharmacokinetics of [14C]-GSK2239633 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01086462
- Acronym / sponsor ID
- 114041
- Conditions
- Asthma
- Keywords
- GSK2239633, RADIOLABEL, PHARMACOKINETICS, INTRAVENOUS, MICRODOSE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2010 (actual)
- Primary completion
- 22 Feb 2010 (actual)
- Study completion
- 22 Feb 2010 (actual)
- First posted
- 15 Mar 2010 (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 first administration to man microdose study to describe the pharmacokinetics of GSK2239633.
Detailed description
The different shapes of the pharmacokinetic (PK) profiles following administration of GSK2239633 in rat and dog make it difficult to reliably predict the human PK profile. This microdose study will provide an early readout on the distribution and clearance profile of the drug in man and will be used to model potential clinical oral doses. The study will be conducted using an open-label, single dose design in one group of healthy male volunteers. Each subject will receive a single intravenous infusion of 100ug GSK2239633 (containing approximately 10kBq of [14C]-GSK2239633), administered over 15 minutes. Subjects will attend for a screening visit within 30 days prior to Day 1 and receive a single dose infusion of study drug on Day 1. Blood and urine samples will be taken over 48 hours for pharmacokinetic and total radioactivity analysis, and safety and tolerability will be monitored. Subjects will be discharged on Day 3 and a follow-up telephone call will be made 4-10 days post-dose.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSK2239633 | Experimental | Drug: GSK2239633Single dose infusion of study drug over 15 minutes |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy subjects are defined as individuals who in the opinion of the Investigator are free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine, neurological and psychiatric disease or malignancy as determined by medical history, physical examination, laboratory studies, and other tests (including ECG). Subjects with values outside the normal range which are deemed to be clinically relevant should always be excluded from enrollment.
- Male between 18 and 50 years of age inclusive, at the time of signing the informed consent.
- Subject must agree to use one of the contraception methods listed in Section 8.1. of the protocol. This criterion must be followed from the time of screening until 90 days after the follow up
- Body weight >or= 50 kg and BMI within range 18.5-29.9 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Key exclusion criteria (17 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- A positive pre-study drug/alcohol screen
- A positive test for HIV antibody
- History of regular alcohol consumption within 6 months of study defined as an average weekly intake of >12 units/week for males. One unit is equivalent to 8g of alcohol; a half-pint (~250ml) of beer, 1 glass (100ml) of wine or 1 (35 ml) measure of spirits.
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 |
|---|---|---|
| GSK2239633100 ug GSK2239633 containing approximately 10kBq [14C]-GSK2239633 | Drug | GSK2239633 |
Primary outcome
Pharmacokinetics (AUC0-inf, Cmax, AUC0-t, t1/2, clearance, volume of distribution) of [14C]-GSK2239633 and total drug-related material
Time frame: 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 18 Jul 2017.
- Background: PubMed 23448278Cahn A, Hodgson S, Wilson R, Robertson J, Watson J, Beerahee M, Hughes SC, Young G, Graves R, Hall D, van Marle S, Solari R. Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633, a CC-chemokine receptor 4 antagonist, in healthy male subjects: results from an open-label and from a randomised study. BMC Pharmacol Toxicol. 2013 Feb 28;14:14. doi: 10.1186/2050-6511-14-14.
- Results for study 114041 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 GSK2239633 in people with Asthma, run by GlaxoSmithKline at 1 site in Netherlands.
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 17 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 18 Jul 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 Netherlands. 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?
Pharmacokinetics (AUC0-inf, Cmax, AUC0-t, t1/2, clearance, volume of distribution) of [14C]-GSK2239633 and total drug-related material (time frame: 48 hours). 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 NCT01086462, 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 18 Jul 2017.