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Trial record 43 of 914 for:    tablet | Japan

Daprodustat Bioequivalence and Food Effect Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03493386
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This is two-way crossover study to compare pharmacokinetic (PK) of daprodustat 2 milligram (mg) versus 4 mg tablets and food effect on the PK of daprodustat following single oral doses in healthy Japanese male subjects. This study will be conducted in two parts. Part 1 is the bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet in fasting and fed state in a crossover manner. There will 5-day wash-out period between each intervention period. There will be approximately 52 subjects in Part 1 and 12 subjects in Part 2. The study will last for 6 weeks.

Condition or disease Intervention/treatment Phase
Anaemia Drug: Daprodustat 2 mg tablet Drug: Daprodustat 4 mg tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study will be conducted in two parts. Part 1 is the bioequivalence part in which subjects will receive single dose of 2 tablets of 2 mg daprodustat and single dose of 1 tablet of 4 mg daprodustat in crossover manner. Part 2 is Food effect part. In this part, subjects will receive single dose of 4 mg daprodustat tablet in fasting and fed state in a crossover manner.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Centre, Single Dose, Open-label, Randomised, 2-way Crossover Study in Healthy Japanese Male Subjects to Evaluate the Bioequivalence of Daprodustat Tablets (2 mg Tablet vs. 4 mg Tablet) (Part 1) and the Food Effect on the Pharmacokinetics of Daprodustat (Part 2)
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : June 9, 2018
Actual Study Completion Date : June 9, 2018

Arm Intervention/treatment
Experimental: Treatment Group A: Part 1
Subjects will be randomized to receive single dose of two tablets of 2 mg daprodustat in Period 1 and in Period 2 subjects will receive single dose of 4 mg daprodustat. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 2 mg tablet
Daprodustat is available as 2 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study.

Drug: Daprodustat 4 mg tablet
Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.

Experimental: Treatment Group B: Part 1
Subjects will be randomized to receive single dose of 4 mg daprodustat in Period 1 and in Period 2 subjects will receive single dose of two tablets of 2 mg daprodustat. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 2 mg tablet
Daprodustat is available as 2 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study.

Drug: Daprodustat 4 mg tablet
Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.

Experimental: Treatment Group C: Part 2
Subjects will be randomized to receive single dose of 4 mg daprodustat in fed state during Period 1 and in Period 2 subjects will receive single dose of 4 mg daprodustat in fasted state. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 4 mg tablet
Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.

Experimental: Treatment Group D: Part 2
Subjects will be randomized to receive single dose of 4 mg daprodustat in fasted state during period 1 and in Period 2 subjects will receive single dose of 4 mg daprodustat in fed state. There will be a wash-out period of 5 days between the Periods.
Drug: Daprodustat 4 mg tablet
Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.




Primary Outcome Measures :
  1. Area under plasma concentration-time curve (AUC) from zero hours to last measurable concentration (AUC[0-t]) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of AUC (0-t)

  2. Fed AUC(0-t) of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of AUC (0-t)

  3. Fasted AUC(0-t) of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of AUC (0-t)

  4. Maximum plasma concentration (Cmax) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of Cmax

  5. Fed Cmax of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of Cmax

  6. Fasted Cmax of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of Cmax

  7. AUC from zero hours extrapolated to infinity (AUC [0-inf]) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of AUC (0-inf)

  8. Fed AUC(0-inf) of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of AUC (0-inf)

  9. Fasted AUC(0-inf) of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of AUC (0-inf)

  10. Time of occurrence of Cmax (Tmax) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of tmax

  11. Fed tmax of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of tmax

  12. Fasted tmax of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of tmax

  13. Terminal phase half-life (T1/2) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of t1/2

  14. Fed t1/2 of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of t1/2

  15. Fasted t1/2 of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of t1/2

  16. Percentage of AUC (0-inf) obtained by extrapolation (percentage AUCex) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of percentage AUCex

  17. Fed percentage AUCex of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of percentage AUCex

  18. Fasted percentage AUCex of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of percentage AUCex

  19. Apparent clearance (CL/F) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of CL/F

  20. Fed CL/F of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of CL/F

  21. Fasted CL/F of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of CL/F

  22. Apparent oral volume of distribution (Vz/F) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of Vz/F

  23. Fed Vz/F of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of Vz/F

  24. Fasted Vz/F of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of Vz/F

  25. Elimination rate constant (kel) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of kel

  26. Fed kel of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of kel

  27. Fasted kel of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of kel

  28. Mean residence time (MRT) of daprodustat: Part 1 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of MRT

  29. Fed MRT of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of MRT

  30. Fasted MRT of daprodustat: Part 2 [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2. ]
    Blood samples will be collected at indicated time points for analysis of MRT


Secondary Outcome Measures :
  1. Number of subjects with adverse events (AEs) and serious AEs (SAEs): Part 1 [ Time Frame: Up to Day 16 ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, may require hospitalization or prolongation of existing hospitalization, result in persistent disability/incapacity, or may led to any congenital anomaly or birth defect.

  2. Number of subjects with AEs and SAEs: Part 2 [ Time Frame: Up to Day 16 ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, may require hospitalization or prolongation of existing hospitalization, result in persistent disability/incapacity, or may led to any congenital anomaly or birth defect.

  3. Number of subjects with abnormal hematology parameters: Part 1 [ Time Frame: Up to Day 16 ]
    Laboratory assessment for hematology parameters will include Platelet count, haemoglobin (Hgb), Red blood cell (RBC) count, hematocrit, RBC indices like mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and percentage reticulocytes. White blood cell (WBC) count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  4. Number of subjects with abnormal hematology parameters: Part 2 [ Time Frame: Up to Day 16 ]
    Laboratory assessment for hematology parameters will include Platelet count, Hgb, RBC count, hematocrit, RBC indices like MCV, MCH, MCHC, and percentage reticulocytes. WBC count with differential will include neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  5. Number of subjects with abnormal clinical chemistry parameters: Part 1 [ Time Frame: Up to Day 16 ]
    Laboratory assessment for clinical chemistry parameters will include blood urea nitrogen (BUN), potassium, calcium, sodium, creatinine, fasting glucose, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline phosphate, total protein, total and direct bilirubin, albumin, uric acid, triglyceride, total cholesterol, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, lactate dehydrogenase, gamma glutamyl transpeptidase (GGT), Creatine phosphokinase (CPK), amylase, chloride, and phosphorus.

  6. Number of subjects with abnormal clinical chemistry parameters: Part 2 [ Time Frame: Up to Day 16 ]
    Laboratory assessment for clinical chemistry parameters will include BUN, potassium, calcium, sodium, creatinine, fasting glucose, AST, ALT, Alkaline phosphate, total protein, total and direct bilirubin, albumin, uric acid, triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol, lactate dehydrogenase, GGT, CPK, amylase, chloride, and phosphorus.

  7. Number of subjects with abnormal urinalysis: Part 1 [ Time Frame: Up to Day 16 ]
    Laboratory assessment for urine analysis will include specific gravity, hydrogen-ion exponent (pH), glucose, blood, ketones, bilirubin, urobilinogen by dipstick, microscopic examination

  8. Number of subjects with abnormal urinalysis: Part 2 [ Time Frame: Up to Day 16 ]
    Laboratory assessment for urine analysis will include specific gravity,pH, glucose, blood, ketones, bilirubin, urobilinogen by dipstick, microscopic examination

  9. Number of subjects with abnormal systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessment : Part 1 [ Time Frame: Up to Day 16 ]
    SBP and DBP will be measured in semi-supine position after 5 minutes rest.

  10. Number of subjects with abnormal SBP and DBP assessment : Part 2 [ Time Frame: Up to Day 16 ]
    SBP and DBP will be measured in semi-supine position after 5 minutes rest.

  11. Number of subjects with abnormal pulse rate: Part 1 [ Time Frame: Up to Day 16 ]
    Pulse rate will be measured in semi-supine position after 5 minutes rest.

  12. Number of subjects with abnormal pulse rate: Part 2 [ Time Frame: Up to Day 16 ]
    Pulse rate will be measured in semi-supine position after 5 minutes rest.

  13. Number of subjects with abnormal body temperature: Part 1 [ Time Frame: Up to Day 16 ]
    Body temperature will be measured in supine position after 5 minutes rest.

  14. Number of subjects with abnormal body temperature: Part 2 [ Time Frame: Up to Day 16 ]
    Body temperature will be measured in supine position after 5 minutes rest.

  15. Number of subjects with abnormal 12-lead electrocardiogram (ECG) parameters: Part 1 [ Time Frame: Up to Day 16 ]
    Single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Friderician formula (QTcF) intervals.

  16. Number of subjects with abnormal 12-lead ECG parameters: Part 2 [ Time Frame: Up to Day 16 ]
    Single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Japanese male subjects who will be overtly healthy as determined by medical evaluation will be included in the study.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be 20 to 55 years of age inclusive, at the time of signing the informed consent.
  • Japanese subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  • Body weight > = 50 kilogram (kg) and body mass index (BMI) within the range 18.5 - 24.9 kilogram per meter square (kg/m^2).
  • Male subjects.
  • Subjects capable of giving signed informed consent.

Exclusion Criteria:

  • History or presence of cardiovascular(CV), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
  • Abnormal blood pressure as determined by the investigator.
  • ALT >1.5x upper limit of normal (ULN).
  • Bilirubin >1.5xULN
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • QTcF > 500 millisecond (msec). The QTcF is the QT interval corrected for heart rate according to Fridericia's formula, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QT correction (QTc) for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.
  • The values of Hgb at screening: >=16.0 gram per deciliter (g/dL).
  • History of deep vein thrombosis, pulmonary embolism or other thrombosis related condition.
  • History of myocardial infarction (MI) or acute coronary syndrome, stroke or transient ischemic attack.
  • Subjects that have undergone cholecystectomy.
  • History of malignancy within the prior 2 years or currently receiving treatment for cancer.
  • Any evidence of heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
  • Past or intended use of over-the-counter or prescription medication including vitamins, diet foods and herbal medications within 14 days prior to first dosing.
  • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
  • Current enrolment or past participation (that is administration of last dose of investigational study intervention) within the last 30 days (or 5 half-lives, whichever is longer) before signing of consent in this clinical study involving an investigational study intervention or any other type of medical research.
  • The subject with positive serological test for syphilis (Rapid Plasma Reagin [RPR] and Treponema pallidum haemagglutination test [TPHA]), Human immunodeficiency virus (HIV) Antigen/Antibody, Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, or Human T-cell lymphotropic virus type 1 (HTLV-1) antibody at screening.
  • Positive pre-study drug screen.
  • Regular alcohol consumption within 6 months prior to the study defined as:for an average weekly intake of >14 units for males. One unit is equivalent to 350 milliliter (mL) of beer, 150 mL of wine or 45 mL of 80 proof distilled spirits.
  • Smoking or history of regular use of tobacco- or nicotine-containing products (example nicotine patch, electronic cigarette) within 6 months prior to screening.
  • Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
  • History of donation of blood or blood products >= 400 mL within 3 months or >= 200 mL within 1 month prior to the first dosing day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493386


Locations
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Japan
GSK Investigational Site
Fukuoka, Japan, 813-0017
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03493386     History of Changes
Other Study ID Numbers: 207727
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Japan
Crossover
Daprodustat
Bioequivalence
Pharmacokinetics

Additional relevant MeSH terms:
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Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs