AnaemiaPhase 1DDINCT01376232
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
A Phase 1 study testing GSK1278863, GSK1278863 + food and Gemfibrozil in people with Anaemia, run by GlaxoSmithKline at 1 site in India.
Trial summary
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),] Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaemia
- What is being tested?
- GSK1278863, GSK1278863 + food and Gemfibrozil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIndia
- Study dates
- 8 Nov 2010to 20 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AST, ALT, alkaline phosphatase and bilirubin > 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- 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 or female between 18 and 55 years of age inclusive, at the time of signing the informed consent
- A female subject is eligible to participate if she is 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 8.1 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 should 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
- 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 terminal half-lives post-last dose
- Body weight < 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block
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)
- The values of hematological parameters at screening are: Any values outside the reference range
- 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
- The values of the following tests at screening are: Serum ferritin: outside the reference range
- A positive test for HIV antibody
Show all 24Show fewer
- Clinically significant CPK >3 X ULN or deemed clinically significant by the investigator
- Calculated creatinine clearance: < 80 mL/min
- Subjects with a pre-exisisting condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function-that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Examples of conditions that could interfere with normal gastriointestinal anatomy or motility include cholecystectomy, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, or celiac sprue
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~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 first dosing day in the current study: 12 weeks, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
- History of peptic ulcer disease
- History of malignancy tumor. Non-melanoma skin cancer that has been definitely removed is allowed
- 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 14 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
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing
- Lactating females
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening
- Consumption of red wine, apples, star fruit, or citrus fruits/juices including blood oranges (with the exception of oranges, mandarins and lemons) from 7 days prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures and compromise subject safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),]
Read the detailed description
The purpose of this study is to assess the clinical drug-drug interaction potential of GSK1278863A with medications that are inhibitors of CYP2C8 enzyme in order to support co-administration of similar agents in later phase development. Specifically. this study will assess the pharmacokinetics of a single dose of GSK1278863A administered alone or co-administered with gemfibrozil, a potent inhibitor of CYP2C8, following steady-state oral administration of gemfibrozil. Finally, to support the co-administration of GSK1278863A with food, this study will assess the pharmacokinetics of a single oral dose of GSK1278863A under fasting conditions and following a standard high-calorie, high fat meal.
- Conditions
- Anaemia
- Being tested
- GSK1278863, GSK1278863 + food, Gemfibrozil
- Keywords
- Anaemia, Drug- Drug Interaction
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1278863Drug
GSk1278863 100mg
GSK1278863 + foodDrug
High Fat meal + 100 mg GSK1278863
GemfibrozilDrug
600 mg Gemfibrozil
| Study group | Role | What they receive |
|---|---|---|
| GSK1278863 | Experimental | 100 mg of GSK1278863 Receives: Drug: GSK1278863 |
| GSK1278863 + food | Experimental | 100 mg of GSK1278863 given with a high fat meal Receives: Drug: GSK1278863 + food |
| GSK1278863 + Gemfibrozil | Experimental | GSK1278863A 100mg + Gemfibrozil 600mg steady state Receives: Drug: Gemfibrozil |
What is being measured
The primary outcome is the main question the study is designed to answer.
GSK1278863A (and metabolites, as appropriate) AUC(0-¥) and Cmax
- To assess the relative bioavailability GSK1278863A following single-dose administration under fasting and fed (standard high fat/calorie meal) conditions
Measured: 48 hours
Secondary outcomes (2)
1. Plasma GSK1278863A (and metabolites, as appropriate) AUC(0-t), tmax, and t1/2.
- To assess the safety and tolerability of GSK1278863A when coadministered with a high-fat meal and steady-state gemfribrozil
Measured: 48hr
Adverse event, clinical laboratory, ECG, vital signs, and concurrent medication assessments.
Safety and tolerability parameters
Measured: 48 hours and duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start8 Nov 2010
- Primary completion20 Dec 2010
- Study completion20 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Octagon Research Solutions, Incoporated
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376232
- Sponsor's protocol ID
- 113634
- Acronym
- DDI
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2011
- Last updated
- 9 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 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
- ClinicalTrials.gov ID
- NCT01376232
- Acronym / sponsor ID
- DDI / 113634
- Conditions
- Anaemia
- Keywords
- Anaemia, Drug- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Octagon Research Solutions, Incoporated
- Study start
- 8 Nov 2010 (actual)
- Primary completion
- 20 Dec 2010 (actual)
- Study completion
- 20 Dec 2010 (actual)
- First posted
- 20 Jun 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.
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),]
Detailed description
The purpose of this study is to assess the clinical drug-drug interaction potential of GSK1278863A with medications that are inhibitors of CYP2C8 enzyme in order to support co-administration of similar agents in later phase development. Specifically. this study will assess the pharmacokinetics of a single dose of GSK1278863A administered alone or co-administered with gemfibrozil, a potent inhibitor of CYP2C8, following steady-state oral administration of gemfibrozil. Finally, to support the co-administration of GSK1278863A with food, this study will assess the pharmacokinetics of a single oral dose of GSK1278863A under fasting conditions and following a standard high-calorie, high fat meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSK1278863 | Experimental | Drug: GSK1278863100 mg of GSK1278863 |
| GSK1278863 + food | Experimental | Drug: GSK1278863 + food100 mg of GSK1278863 given with a high fat meal |
| GSK1278863 + Gemfibrozil | Experimental | Drug: GemfibrozilGSK1278863A 100mg + Gemfibrozil 600mg steady state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- AST, ALT, alkaline phosphatase and bilirubin > 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- 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 or female between 18 and 55 years of age inclusive, at the time of signing the informed consent
- A female subject is eligible to participate if she is 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 8.1 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 should 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
- 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 terminal half-lives post-last dose
Key exclusion criteria (24 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)
- The values of hematological parameters at screening are: Any values outside the reference range
- 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
- The values of the following tests at screening are: Serum ferritin: outside the reference range
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 |
|---|---|---|
| GSK1278863GSk1278863 100mg | Drug | GSK1278863 |
| GSK1278863 + foodHigh Fat meal + 100 mg GSK1278863 | Drug | GSK1278863 + food |
| Gemfibrozil600 mg Gemfibrozil | Drug | GSK1278863 + Gemfibrozil |
Primary outcome
GSK1278863A (and metabolites, as appropriate) AUC(0-¥) and Cmax
Time frame: 48 hours
1. To assess the relative bioavailability GSK1278863A following single-dose administration under fasting and fed (standard high fat/calorie meal) conditions
2 secondary outcomes
1. Plasma GSK1278863A (and metabolites, as appropriate) AUC(0-t), tmax, and t1/2.
Time frame: 48hr
Adverse event, clinical laboratory, ECG, vital signs, and concurrent medication assessments.
Time frame: 48 hours and duration of 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 9 Jun 2017.
- Results for study 113634 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 GSK1278863, GSK1278863 + food and Gemfibrozil in people with Anaemia, run by GlaxoSmithKline at 1 site in India.
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 24 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 9 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 India. 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?
GSK1278863A (and metabolites, as appropriate) AUC(0-¥) and Cmax (time frame: 48 hours). 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 9 Jun 2017.