AsthmaPhase 1NCT01318980
A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915A
A Phase 1 study testing GSK2190915 100mg milled tablet, [14C] radiolabelled GSK2190915 solution and GSK2190915 100mg milled tablet administered to the proximal small bowel. in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes through the blockage of the first step in the leukotriene pathway, 5-lipoxygenase (5-LO) activation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- GSK2190915 100mg milled tablet, [14C] radiolabelled GSK2190915 solution and GSK2190915 100mg milled tablet administered to the proximal small bowel.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2010to 11 Mar 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females as determined by an experienced study physician, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and electrocardiogram (ECG). 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;
- Females must be either:
- Of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 9.4 of the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]
- Of child-bearing potential and agrees to use one of the contraception methods listed in Section 9.4 of the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 3 months after the last dose.
- Aged 18-65 years;
- Body Mass Index (BMI) of 18-35 kilogram per sqare metre (km/m2);
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- Subjects must demonstrate their ability to swallow an empty size 000 capsule;
- Must be willing and able to participate in the whole study and must provide written informed consent;
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5xUpper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);
- QTcB or QTcF < 450 msec
- Subjects of child-bearing potential must agree to use one of the contraception methods listed in Section 9.4 from the time of the first dose of study medication until 3 months following the last dose.
Who cannot join
- Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months or 4 months if new chemical entity (NCE);
- Subjects who have previously been enrolled in this study;
- Subjects who have ever sought advice from or been referred to a General Practitioner or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
- Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;)
- Positive drugs of abuse test result;
- Regular alcohol consumption >14 units per week (1 Unit = ½ pint beer, a 25 milliLitre (mL) shot of 40% spirit or a 125 mL glass of wine);
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- 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 Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening;
- Radiation exposure from clinical trials, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 milliSieverts (mSv) in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study;
- Subjects must not have had any 14C exposure within the last 12 months.
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the Principal Investigator (PI);
- History of gastrointestinal surgery (with the exception of appendectomy unless it was performed within the previous 12 months);
- History of clinically significant cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome;
- History of adverse reaction or allergy to study drug or its excipients, e.g. lactose or rescue medication (if specified by the Sponsor);
- If subject suffers from hayfever they must not have or be expecting to have symptoms during the study period;
- Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before the first study day, this criterion will be determined on first study day. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than three times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day;
- Donation, or significant loss as judged by the investigator, of blood within the previous three months;
- Presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips);
- Subjects will be excluded from the study if they are considered by the PI to be at risk of transmitting, through blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis;
- Positive Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)results;
- Unwillingness or inability to follow the procedures outlined in the protocol;
- Subject is mentally or legally incapacitated;
- Failure to satisfy the PI of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose, Crossover Study in Healthy Female Subjects to Assess the Regional Absorption and Bioavailability of 100 mg GSK2190915A
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes through the blockage of the first step in the leukotriene pathway, 5-lipoxygenase (5-LO) activation. GSK2190915 inhibits the production of leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).
This is an open label, 4-way, 4-treatment period, non-randomised, crossover study with an interim analysis. The GSK2190915 formulations used in this study will be: a 100mg and 200mg milled tablet, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915 intravenous solution.
This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915 to enable optimisation of suitable formulations to be used in clinical development Fourteen subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the subjects will receive an IV microtracer in addition to the other treatments.
Read the detailed description
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes through the blockage of the first step in the leukotriene pathway, 5-lipoxygenase (5-LO) activation. Leukotrienes are potent inflammatory molecules produced mainly by mast cells, eosinophils, monocytes/macrophage and neutrophils in response to allergic or inflammatory stimuli. GSK2190915 inhibits the production of leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).
This is an open label, 4-way, 4 treatment period, non-randomised, single-dose crossover study with an interim analysis following the third treatment period. The GSK2190915 formulations used are: milled 100mg and 200mg tablets, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915 intravenous solution.
There will be 4 periods. Period 1 includes two cohorts (of 7 subjects each), both of which will be administered the 100mg GSK2190915 milled tablet orally; however, the second cohort will in addition be dosed with an intravenous radiolabelled infusion of the drug. In the second period, a 100mg dose of milled GSK2190915 tablet (a ground half of a 200mg tablet) is administered directly to the proximal small bowel using an Enterion capsule. The same dose is repeated in the third period, but is administered directly to the distal small bowel. An interim analysis will then follow. The decision to proceed will be made following a review of the pharmacokinetic data from the first three treatments. In the fourth and final period, the treatment will be a 100mg enteric-coated tablet of GSK2190915 administered orally. There will be a minimum washout of 7 days in between each period.
This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915 to enable optimisation of suitable formulations to be used in clinical development. Periods 1 to 3 will characterise the absolute bioavailability of GSK2190915 using IV tracer and oral formulation, in addition to defining the regional absorption characteristics of the drug when released in the proximal and distal parts of the gastro-intestinal tract. The fourth period will investigate the oral bioavailability of an enteric coated formulation of GSK2190915.
Fourteen subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the subjects (in cohort 2, Period 1) will receive an IV microtracer in addition to the other treatments.
- Conditions
- Asthma
- Being tested
- GSK2190915 100mg milled tablet, [14C] radiolabelled GSK2190915 solution, GSK2190915 100mg milled tablet administered to the proximal small bowel., GSK2190915 100mg milled tablet administered to the distal small bowel., GSK2190915 100mg enteric-coated tablet.
- Keywords
- ADME, IV radiolabelled, pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2190915 100mg milled tabletDrug
Taken orally
[14C] radiolabelled GSK2190915 solutionDrug
Microtracer solution
GSK2190915 100mg milled tablet administered to the proximal small bowel.Drug
Ground half of a 200mg tablet. Administered via Enterion capsule.
GSK2190915 100mg milled tablet administered to the distal small bowel.Drug
Ground half of a 200mg tablet. Administered via Enterion capsule.
GSK2190915 100mg enteric-coated tablet.Drug
Taken orally
| Study group | Role | What they receive |
|---|---|---|
| Period 1 Cohort 1 - GSK2190915 100mg | Experimental | Period 1 - GSK2190915 100mg tablet. Receives: Drug: GSK2190915 100mg milled tablet |
| Period 1 Cohort 2 - GSK2190915 100mg plus microtracer | Experimental | Period 1 - GSK2190915 100mg tablet plus [14C] radiolabelled GSK2190915 microtracer solution. Receives: Drug: GSK2190915 100mg milled tablet; Drug: [14C] radiolabelled GSK2190915 solution |
| Period 2 GSK2190915 100mg to proximal small bowel | Experimental | 100mg of ground half 200mg GSK2190915 tablet administered to the proximal small bowel via Enterion capsule. Receives: Drug: GSK2190915 100mg milled tablet administered to the proximal small bowel. |
| Period 3 GSK2190915 100 mg to distal small bowel | Experimental | 100mg of ground half 200mg GSK2190915 tablet administered to the distal small bowel via Enterion capsule. Receives: Drug: GSK2190915 100mg milled tablet administered to the distal small bowel. |
| Period 4 - GSK 100mg enteric-coated tablet | Experimental | 100mg enteric-coated GSK2190915 coated tablet. Receives: Drug: GSK2190915 100mg enteric-coated tablet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of the maximum concentration (Cmax), the time of Cmax (tmax) and Area Under the plasma concentration-time Curve (AUC) for intravenous and oral pharmacokinetics
Measured: 1 month
Determination of AUC data for all routes of administration to permit calculation of relative and absolute bioavailability where appropriate.
Measured: 1 month
Assessment of regiospecific bioavailability of GSK2190915A based on tmax, Cmax, and AUC to assist in subsequent oral formulation/delivery options for GSK2190915A
Measured: 1 month
Secondary outcomes (3)
To collect further information about the safety and tolerability of GSK2190915A by assessing: physical examination, safety laboratory tests, vital signs, electrocardiogram (ECG), adverse events.
Measured: 1 month
Quantitative and cumulative recovery of radiocarbon in urine and faeces to permit an assessment of deposition route for intravenous GSK2190915A.
Measured: 1 month
Collection of bile to allow profiling of metabolites of GSK2190915A.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study start30 Sep 2010
- Primary completion11 Mar 2011
- Study completion11 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT01318980
- Sponsor's protocol ID
- 114604
- Status last verified
- Aug 2017
- First submitted
- 17 Mar 2011
- Last updated
- 3 Aug 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 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Crossover Study in Healthy Female Subjects to Assess the Regional Absorption and Bioavailability of 100 mg GSK2190915A
- ClinicalTrials.gov ID
- NCT01318980
- Acronym / sponsor ID
- 114604
- Conditions
- Asthma
- Keywords
- ADME, IV radiolabelled, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2010 (actual)
- Primary completion
- 11 Mar 2011 (actual)
- Study completion
- 11 Mar 2011 (actual)
- First posted
- 21 Mar 2011 (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.
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes through the blockage of the first step in the leukotriene pathway, 5-lipoxygenase (5-LO) activation. GSK2190915 inhibits the production of leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).
This is an open label, 4-way, 4-treatment period, non-randomised, crossover study with an interim analysis. The GSK2190915 formulations used in this study will be: a 100mg and 200mg milled tablet, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915 intravenous solution.
This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915 to enable optimisation of suitable formulations to be used in clinical development Fourteen subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the subjects will receive an IV microtracer in addition to the other treatments.
Detailed description
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes through the blockage of the first step in the leukotriene pathway, 5-lipoxygenase (5-LO) activation. Leukotrienes are potent inflammatory molecules produced mainly by mast cells, eosinophils, monocytes/macrophage and neutrophils in response to allergic or inflammatory stimuli. GSK2190915 inhibits the production of leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).
This is an open label, 4-way, 4 treatment period, non-randomised, single-dose crossover study with an interim analysis following the third treatment period. The GSK2190915 formulations used are: milled 100mg and 200mg tablets, a 100mg enteric-coated tablet, and a [14C] radiolabelled GSK2190915 intravenous solution.
There will be 4 periods. Period 1 includes two cohorts (of 7 subjects each), both of which will be administered the 100mg GSK2190915 milled tablet orally; however, the second cohort will in addition be dosed with an intravenous radiolabelled infusion of the drug. In the second period, a 100mg dose of milled GSK2190915 tablet (a ground half of a 200mg tablet) is administered directly to the proximal small bowel using an Enterion capsule. The same dose is repeated in the third period, but is administered directly to the distal small bowel. An interim analysis will then follow. The decision to proceed will be made following a review of the pharmacokinetic data from the first three treatments. In the fourth and final period, the treatment will be a 100mg enteric-coated tablet of GSK2190915 administered orally. There will be a minimum washout of 7 days in between each period.
This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915 to enable optimisation of suitable formulations to be used in clinical development. Periods 1 to 3 will characterise the absolute bioavailability of GSK2190915 using IV tracer and oral formulation, in addition to defining the regional absorption characteristics of the drug when released in the proximal and distal parts of the gastro-intestinal tract. The fourth period will investigate the oral bioavailability of an enteric coated formulation of GSK2190915.
Fourteen subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the subjects (in cohort 2, Period 1) will receive an IV microtracer in addition to the other treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Period 1 Cohort 1 - GSK2190915 100mg | Experimental | Drug: GSK2190915 100mg milled tabletPeriod 1 - GSK2190915 100mg tablet. |
| Period 1 Cohort 2 - GSK2190915 100mg plus microtracer | Experimental | Drug: GSK2190915 100mg milled tablet, Drug: [14C] radiolabelled GSK2190915 solutionPeriod 1 - GSK2190915 100mg tablet plus [14C] radiolabelled GSK2190915 microtracer solution. |
| Period 2 GSK2190915 100mg to proximal small bowel | Experimental | Drug: GSK2190915 100mg milled tablet administered to the proximal small bowel.100mg of ground half 200mg GSK2190915 tablet administered to the proximal small bowel via Enterion capsule. |
| Period 3 GSK2190915 100 mg to distal small bowel | Experimental | Drug: GSK2190915 100mg milled tablet administered to the distal small bowel.100mg of ground half 200mg GSK2190915 tablet administered to the distal small bowel via Enterion capsule. |
| Period 4 - GSK 100mg enteric-coated tablet | Experimental | Drug: GSK2190915 100mg enteric-coated tablet.100mg enteric-coated GSK2190915 coated tablet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy females as determined by an experienced study physician, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and electrocardiogram (ECG). 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;
- Females must be either:
- Of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 9.4 of the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.]
- Of child-bearing potential and agrees to use one of the contraception methods listed in Section 9.4 of the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 3 months after the last dose.
- Aged 18-65 years;
Key exclusion criteria (23 listed)
- Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months or 4 months if new chemical entity (NCE);
- Subjects who have previously been enrolled in this study;
- Subjects who have ever sought advice from or been referred to a General Practitioner or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
- Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;)
- Positive drugs of abuse test result;
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 |
|---|---|---|
| GSK2190915 100mg milled tabletTaken orally | Drug | Period 1 Cohort 1 - GSK2190915 100mg, Period 1 Cohort 2 - GSK2190915 100mg plus microtracer |
| [14C] radiolabelled GSK2190915 solutionMicrotracer solution | Drug | Period 1 Cohort 2 - GSK2190915 100mg plus microtracer |
| GSK2190915 100mg milled tablet administered to the proximal small bowel.Ground half of a 200mg tablet. Administered via Enterion capsule. | Drug | Period 2 GSK2190915 100mg to proximal small bowel |
| GSK2190915 100mg milled tablet administered to the distal small bowel.Ground half of a 200mg tablet. Administered via Enterion capsule. | Drug | Period 3 GSK2190915 100 mg to distal small bowel |
| GSK2190915 100mg enteric-coated tablet.Taken orally | Drug | Period 4 - GSK 100mg enteric-coated tablet |
Primary outcome
Characterisation of the maximum concentration (Cmax), the time of Cmax (tmax) and Area Under the plasma concentration-time Curve (AUC) for intravenous and oral pharmacokinetics
Time frame: 1 month
Determination of AUC data for all routes of administration to permit calculation of relative and absolute bioavailability where appropriate.
Time frame: 1 month
Assessment of regiospecific bioavailability of GSK2190915A based on tmax, Cmax, and AUC to assist in subsequent oral formulation/delivery options for GSK2190915A
Time frame: 1 month
3 secondary outcomes
To collect further information about the safety and tolerability of GSK2190915A by assessing: physical examination, safety laboratory tests, vital signs, electrocardiogram (ECG), adverse events.
Time frame: 1 month
Quantitative and cumulative recovery of radiocarbon in urine and faeces to permit an assessment of deposition route for intravenous GSK2190915A.
Time frame: 1 month
Collection of bile to allow profiling of metabolites of GSK2190915A.
Time frame: 1 month
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 3 Aug 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 114604 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 testing GSK2190915 100mg milled tablet, [14C] radiolabelled GSK2190915 solution and GSK2190915 100mg milled tablet administered to the proximal small bowel. in people with Asthma, 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 23 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 3 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?
Characterisation of the maximum concentration (Cmax), the time of Cmax (tmax) and Area Under the plasma concentration-time Curve (AUC) for intravenous and oral pharmacokinetics (time frame: 1 month). 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 3 Aug 2017.