CancerPhase 1NCT01340846
A Pharmacokinetics Study of the Effects of GSK2118436 on Warfarin, the Effects of Ketoconazole and Gemfibrozil on GSK2118436, and the Effects of Repeat Doses of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
A Phase 1 study testing Warfarin, Ketoconazole and Gemfibrozil in people with Cancer, run by GlaxoSmithKline at 11 sites in 3 countries.
Trial summary
GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Warfarin, Ketoconazole and Gemfibrozil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 3 Sep 2012to 14 Nov 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age at the time of signing the informed consent form;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Body weight >/= 45 kg and a body mass index >/= 19 kg/m2 and </= 35 kg/m2 (inclusive);
- Able to swallow and retain oral medication;
- BRAF V600 mutation-positive tumor as determined in a CLIA-approved laboratory or equivalent (the local BRAF testing may be subject to subsequent verification by centralized testing);
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; NOTE: Subjects with a performance status of 2 can be enrolled if the patient's confinement to bed and inability to carry out work activities is due solely to cancer-related pain, as assessed by the Investigator;
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- Women of child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control. Additionally, women of childbearing potential must have a negative serum pregnancy test within 14 days prior to the first dose of study medication;
- Must have adequate organ function as defined by the following values:
- Absolute neutrophil count (ANC) >/=1.2 x 109/L Hemoglobin >/= 9 g/dL Platelets >/= 100 x 109/L Serum bilirubin >/= 1.5 x Upper Limit of Normal (ULN) AST and ALT >/= 2.5 x ULN; <5 x ULN if liver metastases are present (with approval of GSK medical monitor) Serum creatinine >/= ULN or calculated creatinine clearance >/= 60 mL/min PT/INR and partial thromboplastin time (PTT) >/= 1.3 x ULN Left ventricular ejection fraction >/= institutional lower limit of normal by ECHO
- CYP2C9 genotype of *1/*1 (wildtype), *1/*2 or *1/*3 (Part A only)
Who cannot join
- Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy) within the last three weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks;
- 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: 28 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data);
- Current use of a prohibited medication or herbal preparation or requires any of these medications during the study;
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication;
- History of sensitivity to heparin or heparin-induced thrombocytopenia;
- Any major surgery within the last 4 weeks;
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- Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) [NCI, 2009] Grade 2 from previous anti-cancer therapy except alopecia;
- Presence of active GI disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs. If clarification is needed as to whether a condition will significantly affect absorption of drugs, contact the GSK medical monitor;
- A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (subjects with laboratory evidence of HBV clearance may be enrolled);
- Presence of invasive malignancy, other than the primary diagnosis;
- Parts B and C: Subjects with brain metastases are excluded if their brain metastases are either:
- Symptomatic Treated (surgery, radiation therapy) but not clinically and radiographically stable one month after local therapy, or Asymptomatic and untreated but > 1 cm in the longest dimension Patients with small (≤ 1 cm in the longest dimension), asymptomatic brain metastases that do not need immediate local therapy can be enrolled with the approval of the GSK medical monitor. Subjects on a stable dose of corticosteroids for more than one month, or those who have been off corticosteroids for at least two weeks can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for more than four weeks; Note: Any brain metastases is exclusionary for Part A (must be excluded by prior imaging);
- Corrected QT (QTcB) interval >/= 480 msecs;
- History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks;
- Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; abnormal cardiac valve morphology documented by ECHO (subjects with minimal abnormalities [i.e., mild regurgitation/stenosis] can be entered on study - if clarification is needed as to whether an ECHO abnormality is minimal, please contact the GSK medical monitor); or history of known cardiac arrhythmias (except sinus arrythmias) within the past 24 weeks;
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs, or excipients (note: to date there are no known drugs chemically related to GSK2118436 which are approved by the FDA);
- Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol;
- Subjects with known glucose 6 phosphate dehydrogenase (G6PD) deficiency;
- Pregnant females as determined by positive hCG test at screening or prior to dosing;
- Lactating females who are actively breast feeding;
- Subject is mentally or legally incapacitated;
- Part A only: Use of warfarin or exogenous Vitamin K (other than from dietary sources) within 30 days prior to treatment with study medication;
- Part A only: Subjects with history of GI bleeding, or GI ulceration;
- Part A only: Subjects with known history of Protein C and/or Protein S deficiency, or any other type of coagulopathy;
- Part A only: Subjects requiring any type of anticoagulation, or taking Aspirin at doses greater than 81 mg/day;
- Part A only: Subjects with brain metastases;
- Part A only: Any subject who by history regularly consumes a large quantity of foods rich in vitamin K will be excluded unless he/she restricts the vitamin K intake for at least one week prior to the first dose of warfarin. For study purposes, large quantities of vitamin K-containing food will be defined as 10 or more portions per week of the following: kale, spinach, turnip greens, cauliflower, chick peas, brussels sprouts, green tea, liver, soybean oil and soy protein products.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States8 sites
GSK Investigational Site
Columbus, Ohio, 43210
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Greenville, South Carolina, 29605
GSK Investigational Site
Nashville, Tennessee, 37203
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Salt Lake City, Utah, 84112
GSK Investigational Site
Sarasota, Florida, 34232
GSK Investigational Site
Scottsdale, Arizona, 85259
United Kingdom2 sites
GSK Investigational Site
Headington, OX3 7LJ
GSK Investigational Site
London, W1G 6AD
About this study
Official title: A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repeat Dose Pharmacokinetics of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C: gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol BRF114144.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Warfarin dosed at 15mg on Day 1 and Day 22
KetoconazoleDrug
Ketoconazole dosed at 400mg daily on Days 19 through 22
GemfibrozilDrug
Gemfibrozil dosed at 600mg twice daily on Days 19 through 22
GSK2118436 150mgDrug
GSK2118436 dosed at 150mg twice daily
GSK2118436 75mgDrug
GSK2118436 dosed at 75mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Warfarin dosed at 15mg Receives: Drug: Warfarin; Drug: GSK2118436 150mg |
| Part B | Experimental | Ketoconazole dosed at 400mg Receives: Drug: Ketoconazole; Drug: GSK2118436 75mg |
| Part C | Experimental | Gemfibrozil dosed at 600mg Receives: Drug: Gemfibrozil; Drug: GSK2118436 75mg |
| Part D | Experimental | GSK2118436 dosed alone Receives: Drug: GSK2118436 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of S-warfarin with and without GSK2118436
Measured: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Area under the concentration time curve (AUC) of S-warfarin with and without GSK2118436
Measured: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Maximum plasma concentration (Cmax) of GSK2118436 with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Area under the concentration time curve (AUC) of GSK2118436 with and without an inhibitor
Measured: Up to12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Cmax of GSK2118436 and metabolites after single and multiple 75mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
AUC of GSK2118436 and metabolites after single and multiple 75mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Time to Cmax (Tmax) of GSK2118436 and metabolites after single and multiple 75mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Half-life of GSK2118436 and metabolites after single 75mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1
Cmax of GSK2118436 and metabolites after single and multiple 150mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
AUC of GSK2118436 and metabolites after single and multiple 150mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Tmax of GSK2118436 and metabolites after single and multiple 150mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Half-life of GSK2118436 and metabolites after single 150mg HPMC dose
Measured: Up to 24 hours after dosing on Day 1
Secondary outcomes (15)
Cmax of R-warfarin with and without GSK2118436
Measured: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Time to Cmax (Tmax) of R-warfarin
Measured: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Trough concentration of GSK2118436
Measured: Up to168 hours after dosing on Day 22
Number of subjects with adverse events as a measure of safety and tolerability
Measured: From date of first dose to transition to Rollover protocol BRF114144 (22 - 29 days) or study follow up visit if subject does not transition to BRF114144 (approximately 29 - 39 days)
Tmax for GSK2118436 with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
AUC, Cmax, Tmax and trough concentration of GSK2118436 metabolites with and without an inhibitor, and AUC ratio of metabolites to parent
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Inhibitor concentrations in combination with GSK2118436
Measured: Up to12 hours after dosing on Day 22 (GSK2118436 in combination with inhibitor)
AUC of R-warfarin with and without GSK2118436
Measured: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Terminal half-life (t1/2) of R-warfarin
Measured: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Cmax of GSK2118436
Measured: Up to168 hours after dosing on Day 22
Trough concentration for GSK2118436 with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Cmax of GSK2118436 metabolites with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Tmax of GSK2118436 metabolites with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Trough concentration of GSK2118436 metabolites with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
AUC ratio of metabolites to parent with and without an inhibitor
Measured: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study start3 Sep 2012
- Primary completion14 Nov 2012
- Study completion14 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01340846
- Sponsor's protocol ID
- 113771
- Status last verified
- Nov 2017
- First submitted
- 14 Apr 2011
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Part, Open-Label Study to Evaluate the Effects of Repeat Dose GSK2118436 on the Single Dose Pharmacokinetics of Warfarin, the Effects of Repeat Dose Oral Ketoconazole and Oral Gemfibrozil on the Repeat Dose Pharmacokinetics of GSK2118436, and the Repeat Dose Pharmacokinetics of GSK2118436 in Subjects With BRAF Mutant Solid Tumors
- ClinicalTrials.gov ID
- NCT01340846
- Acronym / sponsor ID
- 113771
- Conditions
- Cancer
- Keywords
- gemfibrozil, BRAF, Drug Interactions, GSK2118436, warfarin, ketoconazole, BRAF inhibitor, oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2012 (actual)
- Primary completion
- 14 Nov 2012 (actual)
- Study completion
- 14 Nov 2012 (actual)
- First posted
- 25 Apr 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.
GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is being developed for the treatment of BRAF mutation-positive tumors. This is a 4-part study (in 4 separate cohorts of subjects) designed to examine the interaction potential of GSK2118436, either as a perpetrator (i.e., effect of GSK2118436 on warfarin; Part A) or victim (i.e., effect of other drugs on GSK2118436; Part B: ketoconazole and Part C: gemfibrozil), as well as to evaluate the single and repeat dose pharmacokinetic parameters of GSK2118436 (Part D). A sufficient number of subjects will be screened to obtain approximately 12 evaluable subjects each for Part A, Part B, Part C and Part D. Following completion of this study, subjects may continue dosing with GSK2118436 in the roll-over study, Protocol BRF114144.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Warfarin, Drug: GSK2118436 150mgWarfarin dosed at 15mg |
| Part B | Experimental | Drug: Ketoconazole, Drug: GSK2118436 75mgKetoconazole dosed at 400mg |
| Part C | Experimental | Drug: Gemfibrozil, Drug: GSK2118436 75mgGemfibrozil dosed at 600mg |
| Part D | Experimental | Drug: GSK2118436 150mgGSK2118436 dosed alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female at least 18 years of age at the time of signing the informed consent form;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Body weight >/= 45 kg and a body mass index >/= 19 kg/m2 and </= 35 kg/m2 (inclusive);
- Able to swallow and retain oral medication;
- BRAF V600 mutation-positive tumor as determined in a CLIA-approved laboratory or equivalent (the local BRAF testing may be subject to subsequent verification by centralized testing);
Key exclusion criteria (27 listed)
- Currently receiving cancer therapy (e.g., chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy) within the last three weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks;
- 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: 28 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is warranted by the data);
- Current use of a prohibited medication or herbal preparation or requires any of these medications during the study;
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication;
- History of sensitivity to heparin or heparin-induced thrombocytopenia;
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 |
|---|---|---|
| WarfarinWarfarin dosed at 15mg on Day 1 and Day 22 | Drug | Part A |
| KetoconazoleKetoconazole dosed at 400mg daily on Days 19 through 22 | Drug | Part B |
| GemfibrozilGemfibrozil dosed at 600mg twice daily on Days 19 through 22 | Drug | Part C |
| GSK2118436 150mgGSK2118436 dosed at 150mg twice daily | Drug | Part A, Part D |
| GSK2118436 75mgGSK2118436 dosed at 75mg twice daily | Drug | Part B, Part C |
Primary outcome
Maximum plasma concentration (Cmax) of S-warfarin with and without GSK2118436
Time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Area under the concentration time curve (AUC) of S-warfarin with and without GSK2118436
Time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Maximum plasma concentration (Cmax) of GSK2118436 with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Area under the concentration time curve (AUC) of GSK2118436 with and without an inhibitor
Time frame: Up to12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Cmax of GSK2118436 and metabolites after single and multiple 75mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
AUC of GSK2118436 and metabolites after single and multiple 75mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Time to Cmax (Tmax) of GSK2118436 and metabolites after single and multiple 75mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Half-life of GSK2118436 and metabolites after single 75mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1
Cmax of GSK2118436 and metabolites after single and multiple 150mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
AUC of GSK2118436 and metabolites after single and multiple 150mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Tmax of GSK2118436 and metabolites after single and multiple 150mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1 and up to 12 hours after dosing on Day 18
Half-life of GSK2118436 and metabolites after single 150mg HPMC dose
Time frame: Up to 24 hours after dosing on Day 1
15 secondary outcomes
Cmax of R-warfarin with and without GSK2118436
Time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Time to Cmax (Tmax) of R-warfarin
Time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Trough concentration of GSK2118436
Time frame: Up to168 hours after dosing on Day 22
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: From date of first dose to transition to Rollover protocol BRF114144 (22 - 29 days) or study follow up visit if subject does not transition to BRF114144 (approximately 29 - 39 days)
Tmax for GSK2118436 with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
AUC, Cmax, Tmax and trough concentration of GSK2118436 metabolites with and without an inhibitor, and AUC ratio of metabolites to parent
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Inhibitor concentrations in combination with GSK2118436
Time frame: Up to12 hours after dosing on Day 22 (GSK2118436 in combination with inhibitor)
AUC of R-warfarin with and without GSK2118436
Time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Terminal half-life (t1/2) of R-warfarin
Time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)
Cmax of GSK2118436
Time frame: Up to168 hours after dosing on Day 22
Trough concentration for GSK2118436 with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Cmax of GSK2118436 metabolites with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Tmax of GSK2118436 metabolites with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
Trough concentration of GSK2118436 metabolites with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
AUC ratio of metabolites to parent with and without an inhibitor
Time frame: Up to 12 hours after dosing on Day 18 (GSK2118436 alone) and Day 22 (GSK2118436 in combination with inhibitor)
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 13 Nov 2017.
- Results for study 113771 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Warfarin, Ketoconazole and Gemfibrozil in people with Cancer, run by GlaxoSmithKline at 11 sites in 3 countries.
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 10 inclusion and 27 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom, Australia. 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?
Maximum plasma concentration (Cmax) of S-warfarin with and without GSK2118436 (time frame: Up to 168 hours after dosing on Day 1 (warfarin alone) and Day 22 (warfarin in combination with GSK2118436)). The study lists 12 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 13 Nov 2017.