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

9 ottobre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

72

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 99 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 0.5mg GSK1278863
Once daily
Droga: GSK1278863
Tablet
Sperimentale: 2mg GSK1278863
Once daily
Droga: GSK1278863
Tablet
Sperimentale: 5mg GSK1278863
Once daily
Droga: GSK1278863
Tablet
Sperimentale: Placebo
Once daily
Altro: Placebo
Tavoletta

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Modeled Hgb Change From Baseline Over 4 Weeks of Treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Model-Adjusted Maximum Hgb Changes Over 4 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Collaboratori

PPD

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 maggio 2012

Completamento primario (Effettivo)

7 maggio 2013

Completamento dello studio (Effettivo)

7 maggio 2013

Date di iscrizione allo studio

Primo inviato

19 aprile 2012

Primo inviato che soddisfa i criteri di controllo qualità

26 aprile 2012

Primo Inserito (Stima)

30 aprile 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 ottobre 2017

Ultimo verificato

1 agosto 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 116581

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

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

Dati/documenti di studio

  1. Piano di analisi statistica
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Specifica del set di dati
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Protocollo di studio
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Rapporto di studio clinico
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Set di dati del singolo partecipante
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di consenso informato
    Identificatore informazioni: 116581
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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