Pain, InflammatoryPhase 1NCT00849134
First Time in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food of Single Assending Doses of GSK1482160.
A Phase 1 study of Pain, Inflammatory, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a first-time-in-human study. The overall purpose of the study is to assess whether the drug is safe and well tolerated after single, increasing doses. At different doses, we will look to see how much of the drug gets into the bloodstream, how the drug is broken down and excreted and whether this is affected by… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammatory
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2008to 6 Apr 2009
- 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 as determined by a responsible 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 or female aged between 18 and 55 years inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential:
- Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and oestradiol < 40 pg/ml (<140 pmol/L) is confirmatory.]1
- Male subjects 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 5 x terminal half-lives after the last dose.
- Body weight > 50 kg and BMI within the range 18.5 - 29.9 kg/m2 (inclusive).
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- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. The written informed consent form should be signed and dated.
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block. A 12-lead ECG at pre-study screening, which in the opinion of the Principal Investigator or physician designee has no abnormalities that will compromise safety in this study. The specific inclusion criterion with regard to QT interval (either QTcb or QTcf, machine or manual over-read, males or females) is that QTc should be less than 450msec (based on single or average QTc of triplicate ECGs obtained over a brief recording period).
- No abnormality on relevant clinical chemistry or haematology examination at the pre-study medical examination. Subjects with laboratory parameters outside the reference range for this age group will only be included if the principal Investigator or designee considers that such findings will not introduce additional risk factors. Consultation with the GSK medical monitor is required before such subjects may be included. In any case, liver function tests (including bilirubin, ALT, AST or alkaline phosphatase) and markers of renal function (including urea and creatinine) must be strictly within the normal range at screening.
- Normal physical examination (providing no evidence of clinically active disease or physical or mental impairment). A subject with a clinical abnormality may be included only if the Principal Investigator or physician designee considers that the abnormality will not introduce additional risk factors and will not interfere with study procedures. Consultation with the GSK medical monitor is required before such subjects may be included.
- A 24-hour Holter at pre-study screening, which in the opinion of the Principal investigator or physician designee has no abnormalities that will compromise safety in this study. If a rhythm abnormality is detected, the subject may be included in the study only if the Principle Investigator or physician designee considers that the abnormality will not introduce additional risk factors and will not interfere with study procedures. Consultation with Principal Investigator, GSK medical monitor and, if required, a specialist cardiologist will occur before such a subject may be included.
Who cannot join
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- Subjects with any risk factors for tuberculosis that include: (i) a history of either congenital or acquired immunosuppression (e.g. HIV), (ii) a history of any disorder that may be a function of altered immunomodulation (e.g. autoimmune disease), (iii) a history of any clinical condition or surgical procedure that places them at higher risk of TB (e.g. diabetes, sarcoidosis, gastrectomy and vagotomy, malignancy, leukaemia), (iv) a history of mycobacterial infection, including TB, (v) recent close contact (within the previous 48 months) with an individual known to be infected with TB, (vi) recent immigrants or residents (within the previous 48 months) from countries where TB is considered to be of high-prevalence. For the purposes of TB screening amongst applicants for UK visas, high prevalence countries include Bangladesh, Ghana, Burkina Faso, Cote d'Ivoire, Togo, Niger, Kenya, Eritrea, Somalia, Pakistan, Sudan, Tanzania, Thailand, Cambodia and Laos (http://www.ukvisasgov.uk/en/howtoapply/tbscreening).
- History of regular excessive alcohol consumption within 6 months of the study defined as:
- an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
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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 the first 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, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) 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 that the medication will not interfere with the study procedures or compromise subject safety.ONFIDENTIAL HH2007/00234/
- 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 90 day period before the screening visit.
- Pregnant females as determined by positive serum hCG test at screening or urine hCG test prior to dosing.
- Lactating females.
- Females of child-bearing potential
- Females receiving Hormone Replacement Theory
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Urinary cotinine levels indicative of smoking or a history of regular use of tobaccoor nicotine-containing products within 6 months prior to screening.
- Has a resting systolic blood pressure which is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg or heart rate is outside the range 90 to 40 bpm.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2GG
About this study
Official title: A First-Time-in-Human Randomised, Single Blind Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Single Escalating Doses of GSK1482160, in Male and Female Healthy Subjects, and to Make a Preliminary Assessment of the Effect of Food.
This is a first-time-in-human study. The overall purpose of the study is to assess whether the drug is safe and well tolerated after single, increasing doses. At different doses, we will look to see how much of the drug gets into the bloodstream, how the drug is broken down and excreted and whether this is affected by the presence of food.
Read the detailed description
GSK1482160 is a new drug to be developed for treating inflammatory pain (for example, arthritis). It acts on structures on inflammatory cells, known as P2X7 receptors. Blocking these receptors reduces the release of important inflammatory chemicals which exists within the body and are thought to play an important role in promoting inflammatory pain.
This study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (any side effects that make taking the drug unpleasant). Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 8 healthy male or female volunteers will be enrolled into the study. In addition, part of the study will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal.
- Conditions
- Pain, Inflammatory
- Being tested
- GSK1482160 or placebo
- Keywords
- First-Time-in-Human, Tolerability, Pharmacodynamics, Safety, Food Effect, Pharmacokinetics, Healthy Volunteers
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1482160 or placeboDrug
GSK1482160 is a P2X7 receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1,2 & 3 | Placebo comparator | This part of the study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (i.e. possible presence of any side effects that make taking the drug unpleasant) of increasing the study drug. Effects will be compared to those seen when a placebo is taken. Up to 3 groups of 8 healthy male and female volunteers may be enrolled. Receives: Drug: GSK1482160 or placebo |
| Cohort 4 | Active comparator | If an investigation of food effect is not possible in Cohorts 2 or 3, this Cohort will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal. Receives: Drug: GSK1482160 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters, adverse events, change from baseline and number of subjects outside the normal range for blood pressure, heart rate, 12-lead electrocardiogram (ECG) and clinical laboratory parameters.
Measured: Throughout study
Levels of GSK1482160 and any breakdown products in the blood and urine.
Measured: Throughout study
Measuring the amount of inhibition of inflammatory chemical release from blood following dosing with GSK1482160.
Measured: Throughout study
Secondary outcomes (1)
Levels of GSK1482160 and any breakdown products in the blood and urine when taken with and without food.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study start17 Nov 2008
- Primary completion6 Apr 2009
- Study completion6 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, InflammatoryStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 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
- NCT00849134
- Sponsor's protocol ID
- 111383
- Status last verified
- Jul 2017
- First submitted
- 12 Feb 2009
- Last updated
- 7 Jul 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 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-Time-in-Human Randomised, Single Blind Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Single Escalating Doses of GSK1482160, in Male and Female Healthy Subjects, and to Make a Preliminary Assessment of the Effect of Food.
- ClinicalTrials.gov ID
- NCT00849134
- Acronym / sponsor ID
- 111383
- Conditions
- Pain, Inflammatory
- Keywords
- First-Time-in-Human, Tolerability, Pharmacodynamics, Safety, Food Effect, Pharmacokinetics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2008 (actual)
- Primary completion
- 6 Apr 2009 (actual)
- Study completion
- 6 Apr 2009 (actual)
- First posted
- 23 Feb 2009 (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 is a first-time-in-human study. The overall purpose of the study is to assess whether the drug is safe and well tolerated after single, increasing doses. At different doses, we will look to see how much of the drug gets into the bloodstream, how the drug is broken down and excreted and whether this is affected by the presence of food.
Detailed description
GSK1482160 is a new drug to be developed for treating inflammatory pain (for example, arthritis). It acts on structures on inflammatory cells, known as P2X7 receptors. Blocking these receptors reduces the release of important inflammatory chemicals which exists within the body and are thought to play an important role in promoting inflammatory pain.
This study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (any side effects that make taking the drug unpleasant). Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 8 healthy male or female volunteers will be enrolled into the study. In addition, part of the study will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1,2 & 3 | Placebo comparator | Drug: GSK1482160 or placeboThis part of the study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (i.e. possible presence of any side effects that make taking the drug unpleasant) of increasing the study drug. Effects will be compared to those seen when a placebo is taken. Up to 3 groups of 8 healthy male and female volunteers may be enrolled. |
| Cohort 4 | Active comparator | Drug: GSK1482160 or placeboIf an investigation of food effect is not possible in Cohorts 2 or 3, this Cohort will be used to check if there is a difference in the blood levels of the study drug when taken with or without a high fat meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy as determined by a responsible 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 or female aged between 18 and 55 years inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential:
- Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and oestradiol < 40 pg/ml (<140 pmol/L) is confirmatory.]1
- Male subjects 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 5 x terminal half-lives after the last dose.
Key exclusion criteria (18 listed)
- The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for HIV antibody.
- Subjects with any risk factors for tuberculosis that include: (i) a history of either congenital or acquired immunosuppression (e.g. HIV), (ii) a history of any disorder that may be a function of altered immunomodulation (e.g. autoimmune disease), (iii) a history of any clinical condition or surgical procedure that places them at higher risk of TB (e.g. diabetes, sarcoidosis, gastrectomy and vagotomy, malignancy, leukaemia), (iv) a history of mycobacterial infection, including TB, (v) recent close contact (within the previous 48 months) with an individual known to be infected with TB, (vi) recent immigrants or residents (within the previous 48 months) from countries where TB is considered to be of high-prevalence. For the purposes of TB screening amongst applicants for UK visas, high prevalence countries include Bangladesh, Ghana, Burkina Faso, Cote d'Ivoire, Togo, Niger, Kenya, Eritrea, Somalia, Pakistan, Sudan, Tanzania, Thailand, Cambodia and Laos (http://www.ukvisasgov.uk/en/howtoapply/tbscreening).
- History of regular excessive alcohol consumption within 6 months of the study defined as:
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 |
|---|---|---|
| GSK1482160 or placeboGSK1482160 is a P2X7 receptor antagonist | Drug | Cohort 1,2 & 3, Cohort 4 |
Primary outcome
Safety parameters, adverse events, change from baseline and number of subjects outside the normal range for blood pressure, heart rate, 12-lead electrocardiogram (ECG) and clinical laboratory parameters.
Time frame: Throughout study
Levels of GSK1482160 and any breakdown products in the blood and urine.
Time frame: Throughout study
Measuring the amount of inhibition of inflammatory chemical release from blood following dosing with GSK1482160.
Time frame: Throughout study
1 secondary outcome
Levels of GSK1482160 and any breakdown products in the blood and urine when taken with and without food.
Time frame: Throughout study
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 Jul 2017.
- 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.
- Results for study 111383 can be found on the GSK Clinical Study Register.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 of Pain, Inflammatory, 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 11 inclusion and 18 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 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 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. Some participants in this study may receive a placebo. 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 parameters, adverse events, change from baseline and number of subjects outside the normal range for blood pressure, heart rate, 12-lead electrocardiogram (ECG) and clinical laboratory parameters. (time frame: Throughout study). 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?
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 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.