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4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis

2017年10月9日 更新者：GlaxoSmithKline

A Four-week Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Recombinant Human Erythropoietin and Are Not Undergoing Dialysis

This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The study consists of a screening phase of up to 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion. Study treatment will be stopped if Hgb values fall outside of the range pre-specified in the protocol.

This study aims to estimate the relationship between dose of GSK1278863 and Hgb response for correcting anemia in non-dialysis subjects with CKD who are not taking rhEPO (NDD). In addition, the study will characterize the effect of GSK1278863 on various pharmacokinetic/pharmacodynamic (PK/PD) markers, and will investigate the safety and tolerability of GSK1278863.

An early interim analysis of the Hgb data is planned after approximately 20 subjects from cohort 1 have completed 3 weeks of treatment. Depending upon the interim findings, a second cohort of subjects may be added to investigate an additional GSK1278863 dose arm. Recruitment to the first cohort will continue during the interim analysis.

A second interim analysis is planned after approximately 48 subjects from cohort 1 have completed 4 weeks treatment. The purpose of this interim is three-fold, to investigate whether a second cohort of subjects may be added, to facilitate early development of dose-response and PK/PD statistical models, and to generate interim results to facilitate design and dosing decisions for the next trial.

Subject completion is defined as completion of all study phases including the follow-up phase.

研究の種類

介入

入学 (実際)

72

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Azusa、California、アメリカ、91702
        • GSK Investigational Site
      • Bakersfield、California、アメリカ、93309
        • GSK Investigational Site
      • Chino、California、アメリカ、91710
        • GSK Investigational Site
      • Los Angeles、California、アメリカ、90025
        • GSK Investigational Site
      • Los Angeles、California、アメリカ、90022
        • GSK Investigational Site
      • Los Angeles、California、アメリカ、90057
        • GSK Investigational Site
      • North Hollywood、California、アメリカ、91606-1559
        • GSK Investigational Site
      • Orange、California、アメリカ、92868
        • GSK Investigational Site
      • Riverside、California、アメリカ、92505
        • GSK Investigational Site
      • San Dimas、California、アメリカ、91773
        • GSK Investigational Site
      • West Hills、California、アメリカ、91307
        • GSK Investigational Site
      • Yuba City、California、アメリカ
        • GSK Investigational Site
    • Colorado
      • Denver、Colorado、アメリカ、80230
        • GSK Investigational Site
    • Florida
      • Daytona Beach、Florida、アメリカ、32117
        • GSK Investigational Site
      • Edgewater、Florida、アメリカ、32132
        • GSK Investigational Site
      • Fort Lauderdale、Florida、アメリカ、33308
        • GSK Investigational Site
      • Jacksonville、Florida、アメリカ、32258
        • GSK Investigational Site
      • Miami、Florida、アメリカ、33173
        • GSK Investigational Site
      • Miami、Florida、アメリカ、33150
        • GSK Investigational Site
      • Miami、Florida、アメリカ、33145
        • GSK Investigational Site
      • Ocala、Florida、アメリカ、34471
        • GSK Investigational Site
      • Pembroke Pines、Florida、アメリカ、33028
        • GSK Investigational Site
      • Port Charlotte、Florida、アメリカ、33952
        • GSK Investigational Site
    • Georgia
      • Savannah、Georgia、アメリカ、31406
        • GSK Investigational Site
    • Illinois
      • Evanston、Illinois、アメリカ、60201
        • GSK Investigational Site
      • Gurnee、Illinois、アメリカ、60031
        • GSK Investigational Site
    • Michigan
      • Detroit、Michigan、アメリカ、48236
        • GSK Investigational Site
    • North Carolina
      • Asheville、North Carolina、アメリカ、28801
        • GSK Investigational Site
      • Charlotte、North Carolina、アメリカ
        • GSK Investigational Site
      • Wilmington、North Carolina、アメリカ、28401
        • GSK Investigational Site
      • Winston-Salem、North Carolina、アメリカ、27103
        • GSK Investigational Site
    • Ohio
      • Columbus、Ohio、アメリカ、43210
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73116
        • GSK Investigational Site
    • Oregon
      • Portland、Oregon、アメリカ、97210
        • GSK Investigational Site
    • Pennsylvania
      • Bethlehem、Pennsylvania、アメリカ、18017
        • GSK Investigational Site
      • Erie、Pennsylvania、アメリカ、16507
        • GSK Investigational Site
      • Uniontown、Pennsylvania、アメリカ、15401
        • GSK Investigational Site
    • Texas
      • Arlington、Texas、アメリカ、76011
        • GSK Investigational Site
      • Austin、Texas、アメリカ、78751
        • GSK Investigational Site
      • Corsicana、Texas、アメリカ、75110
        • GSK Investigational Site
      • Greenville、Texas、アメリカ、75402
        • GSK Investigational Site
      • Houston、Texas、アメリカ、77099
        • GSK Investigational Site
      • Houston、Texas、アメリカ、77054
        • GSK Investigational Site
      • San Antonio、Texas、アメリカ、78229
        • GSK Investigational Site
      • Temple、Texas、アメリカ、76502
        • GSK Investigational Site
    • Washington
      • Silverdale、Washington、アメリカ、98383
        • GSK Investigational Site
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2R 0X7
        • GSK Investigational Site
    • Ontario
      • Brampton、Ontario、カナダ、L6T 0G1
        • GSK Investigational Site
      • London、Ontario、カナダ、N6A 5A5
        • GSK Investigational Site
      • Sudbury、Ontario、カナダ、P3E 5J1
        • GSK Investigational Site
  • ドイツ
      • Hamburg、ドイツ、22297
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg、Baden-Wuerttemberg、ドイツ、69120
        • GSK Investigational Site
    • Bayern
      • Aschaffenburg、Bayern、ドイツ、63741
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Demmin、Mecklenburg-Vorpommern、ドイツ、17109
        • GSK Investigational Site
    • Niedersachsen
      • Lehrte、Niedersachsen、ドイツ、31275
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age and weight: >/= 18 years of age and >/= 45 kg.
  2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or peritoneal dialysis) or dialysis planned during the time the subject would be enrolled in the study.
  3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta), peginesatide or their biosimilars..
  4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal Disease (MDRD).
  5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2.
  6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months).
  7. Folate: >/=2.0 ng/mL at Screening. May rescreen in a month.
  8. Ferritin: >/=40 ng/mL with the absence of microcytic or hypochromic RBCs.
  9. TSAT within the reference range.
  10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if required, that will be maintained throughout the study. NOTE: IV iron replacement therapy is not allowed the two weeks prior to Screening through the end of the study (Week 6).
  11. QTc: QTcB <470 msec or QTcB <480 msec in subjects with bundle branch block obtained at Screening Visit, based on Central Reader's interpretation.
  12. Females: Eligible to participate if she is of childbearing potential, and must agree to use approved contraception methods from Screening until completion of the Follow-up Visit OR of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH)>40 MIU/ml and estradiol <40 pg/ml is confirmatory]. Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the approved contraception methods 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 types of HRT, at least 2 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.
  13. Males: Must agree to use approved contraceptive methods from the time of Screening until completion of the Follow-up Visit.

Exclusion Criteria:

  1. Dialysis: Planning to initiate dialysis during the study or who have a high potential for initiating dialysis during study participation.
  2. Renal transplant: Renal transplant anticipated or scheduled within the study time period or subjects with a functioning renal transplant.
  3. Total CPK: >5x the upper limit of the reference range.
  4. HIV: Positive HIV antibody.
  5. History of myocardial infarction or acute coronary syndrome within the prior 6 months.
  6. History of stroke or TIAs.
  7. Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
  8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or lack of treatment, defined as DBP >100 mmHg or SBP>160 mmHg.
  9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), or other thrombosis related condition) within the prior 6 months.
  10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g., significant heart failure or lung disease requiring supplemental oxygen, or those with connective tissue diseases).
  11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease).
  12. Hematological disease: Any hematological disease including those affecting platelets, the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) or any other cause of anemia other than renal disease.
  13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests [alkaline phosphatase, ALT or AST > 2.0 x upper limit of normal (ULN) or total bilirubin > 1.5 x ULN]; or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study.
  14. Major surgery: Within the prior 12 weeks or planned during the study.
  15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study.
  16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer disease or active GI bleeding within the prior 12 weeks.
  17. Acute infection: Clinical evidence of acute infection or history of infection requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening through Day 1 (randomization).
  18. Malignancy: History of malignancy within 5 years of Screening or are receiving treatment for cancer or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated.
  19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the Investigator, including subjects with parathyroid hormone (PTH) values ≥600 pg/mL.
  20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12 months, or macular edema requiring treatment.
  21. Severe reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
  22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening until the Follow-up Visit.
  23. Androgens: New androgen therapy or changes to pre-existing androgen regimen within prior 12 weeks.
  24. Prior investigational product exposure: The subject has participated in a clinical trial and has received an experimental investigational product within prior 30 days.
  25. Protocol compliance: Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol.
  26. Other conditions: Any condition which in the investigators opinion should exclude the subject from participating in the study.
  27. Pregnancy and lactation: Pregnant females as determined by positive urine hCG test, OR women who are lactating at Screening or during the trial.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：0.5mg GSK1278863
Once daily
薬：GSK1278863
Tablet
実験的：2mg GSK1278863
Once daily
薬：GSK1278863
Tablet
実験的：5mg GSK1278863
Once daily
薬：GSK1278863
Tablet
実験的：Placebo
Once daily
他の：プラセボ
タブレット

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Modeled Hgb Change From Baseline Over 4 Weeks of Treatment
時間枠：Baseline (average of Week -2, -1 and Day 1) and Week 4
Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (average of Week -2, -1 and Day 1) and Week 4

二次結果の測定

結果測定
メジャーの説明
時間枠
Model-Adjusted Maximum Hgb Changes Over 4 Weeks
時間枠：Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks
Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks
Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb
時間枠：Up to 4 weeks
Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.
Up to 4 weeks
Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb
時間枠：Up to 4 weeks
Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.
Up to 4 weeks
Number of Participants Who Reached Hgb Stopping Criteria
時間枠：Up to Week 4
The Hgb stopping criteria was defined as reaching to value <8.0 g/dL, >=8.0 - <13.0 (>= 2g/dL absolute Hgb change over 1 week ) or >=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented.
Up to Week 4
Change From Baseline in Hepcidin at Week 2 and Week 4
時間枠：Baseline (Pre-dose on Day 1), Week 2 and 4
Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed.
Baseline (Pre-dose on Day 1), Week 2 and 4
Change From Baseline in Ferritin at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in Transferrin at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in Transferrin Saturation at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in Total Iron at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4
Change From Baseline in Erythropoietin at Week 2 and Week 4
時間枠：Baseline (Day 1 Pre-dose), Week 2 and 4
Blood samples for erythropoietin were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 Pre-dose), Week 2 and 4
Change From Baseline in Red Blood Cells Count Over 4 Weeks
時間枠：Baseline (Day 1 pre-dose), week 1, 2, 3, 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Baseline (Day 1 pre-dose), week 1, 2, 3, 4
Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4
時間枠：Baseline (Pre-dose), week 2 and 4
Blood samples for VEGF were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). Baseline was the Day 1 pre-dose value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Baseline (Pre-dose), week 2 and 4
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Up to 6 weeks
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Up to 6 weeks
Number of Participants Discontinuing the Study Treatment Due to AEs
時間枠：Up to 6 weeks
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. number of participants discontinuing the study treatment due to AEs.
Up to 6 weeks
Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 2, 4, and 6
Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 2, 4, and 6
Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 2, 4, and 6
Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 2, 4, and 6
Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 2, 4, and 6
Clinical chemistry parameters including calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 2, 4, and 6
Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 2, 4, and 6
Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 2, 4, and 6
Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6
時間枠：Baseline (Day 1), Week 2, 4, and 6
Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported.
Baseline (Day 1), Week 2, 4, and 6
Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6
時間枠：Baseline (Day 1), Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the Baseline value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Change from Baseline values of ALT, AST, ALP and CK at Week 2, 4, and 6
Baseline (Day 1), Week 2, 4, and 6
Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6
時間枠：Baseline (Day 1), Week 2, 4, and 6
Baseline values were recorded on Day 1 (Pre dose). If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of albumin, apolipoprotein A1, apolipoprotein total, total protein at Week 2, 4, and 6 were reported.
Baseline (Day 1), Week 2, 4, and 6
Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6
時間枠：Baseline (Day 1), Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium at Week 2, 4, and 6 were reported.
Baseline (Day 1), Week 2, 4, and 6
Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6
時間枠：Baseline (Day 1), Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported.
Baseline (Day 1), Week 2, 4, and 6
Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6
時間枠：Baseline (Day 1), Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported.
Baseline (Day 1), Week 2, 4, and 6
Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, WBC count (absolute) were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1), Week 1, 2, 3, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported.
Baseline (Day 1), Week 1, 2, 3, 4, and 6
Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1), Week 1, 2, 3, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported.
Baseline (Day 1), Week 1, 2, 3, 4, and 6
Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1), Week 1, 2, 3, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported.
Baseline (Day 1), Week 1, 2, 3, 4, and 6
Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute values of systolic blood pressure and diastolic blood pressure Baseline (Day 1), Week 1, 2, 3, 4, and 6 as vital parameters were reported. Three measurements of systolic blood pressure and diastolic blood pressure were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Three measurements of SBP and DBP were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in systolic blood pressure and diastolic blood pressure at Week 1, 2, 3, 4, and 6 were reported.
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute values of heart rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 were reported as vital parameter. Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6
時間枠：Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. change from baseline in heart rate at Week 1, 2, 3, 4, and 6 were reported.
Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6
時間枠：Baseline (Screening), Week 2, 4, and 6
Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Absolute ECG parameters including PR interval, QT interval and QRS duration values at Baseline (Screening), Week 2, 4, and 6 were reported.
Baseline (Screening), Week 2, 4, and 6
Change From Baseline in ECG Parameters at Week 2, 4 and 6
時間枠：Baseline (Screening), Week 2, 4, and 6
Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Baseline (Screening), Week 2, 4, and 6
Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites
時間枠：Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Cmax of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For assessment of Pharmacokinetics parameters blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites
時間枠：Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose)
Mean Steady state AUC of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For pharmacokinetic parameter assessment blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this fist sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

協力者

PPD

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2012年5月17日

一次修了 (実際)

2013年5月7日

研究の完了 (実際)

2013年5月7日

試験登録日

最初に提出

2012年4月19日

QC基準を満たした最初の提出物

2012年4月26日

最初の投稿 (見積もり)

2012年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月9日

QC基準を満たした最後の更新が送信されました

2017年10月9日

最終確認日

2017年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 116581

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

試験データ・資料

  1. 統計分析計画
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. データセット仕様
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究プロトコル
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 注釈付き症例報告書
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 臨床研究報告書
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. 個人参加者データセット
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. インフォームド コンセント フォーム
    情報識別子：116581
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

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