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Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers

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: NCT04532918
Recruitment Status : Active, not recruiting
First Posted : August 31, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK). The study is conducted in accordance with Food and Drug Administration guidance on Clinical Drug Interaction Studies, 2020. Verinurad will be developed as a fixed combination since it will always be administered together with allopurinol.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Verinurad Drug: Allopurinol Drug: Cyclosporine Drug: Rifampicin Phase 1

Detailed Description:

This Phase 1 study will be an open-label, 3-period, 3-treatment, fixed-sequence study in healthy subjects (males and females of non-childbearing potential), performed at a single Clinical Unit.

The study will comprise of the following periods (visits):

  • A Screening Period (Visit 1);
  • A fixed sequence of 3 Treatment Periods during which subjects will be resident at the Clinical Unit from one day prior to administration of verinurad+allopurinol (Day -1) of Treatment Period 1 until the morning of Day 5 of the Treatment Period 2, and similarly for Treatment Period 3. There will be a washout period between Treatment Periods 2 and 3 dosing. The 3 Treatment Periods, include the washout period (Visits 2 to 3);
  • A Follow-up Visit, after the last administration of verinurad+allopurinol (Visit 4).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Fixed-sequence
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, 3-Treatment, 3-Period, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Verinurad and Allopurinol When Administered Alone, and in Combination With Single Doses of Cyclosporine or Rifampicin
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : November 13, 2020
Estimated Study Completion Date : November 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Verinurad + allopurinol
The subjects will receive single oral dose of verinurad 7.5 mg and allopurinol 300 mg under fasted condition.
Drug: Verinurad
The subjects will receive single oral dose of extended release capsule verinurad 7.5 mg on Day 1 of each treatment period under fasted condition.

Drug: Allopurinol
The subjects will receive single oral dose of tablet allopurinol 300 mg on Day 1 of each treatment period under fasted condition.

Experimental: Verinurad + allopurinol + cyclosporine
The subjects will receive single oral dose of verinurad 7.5 mg, allopurinol 300 mg and cyclosporine 600 mg under fasted condition.
Drug: Verinurad
The subjects will receive single oral dose of extended release capsule verinurad 7.5 mg on Day 1 of each treatment period under fasted condition.

Drug: Allopurinol
The subjects will receive single oral dose of tablet allopurinol 300 mg on Day 1 of each treatment period under fasted condition.

Drug: Cyclosporine
The subjects will receive single oral dose of soft capsule cyclosporine 600 mg on Day 1 of treatment period 2 under fasted condition.
Other Name: Sandimmun Optoral

Experimental: Verinurad + allopurinol + rifampicin
The subjects will receive single oral dose of verinurad 7.5 mg, allopurinol 300 mg and rifampicin 600 mg under fasted condition.
Drug: Verinurad
The subjects will receive single oral dose of extended release capsule verinurad 7.5 mg on Day 1 of each treatment period under fasted condition.

Drug: Allopurinol
The subjects will receive single oral dose of tablet allopurinol 300 mg on Day 1 of each treatment period under fasted condition.

Drug: Rifampicin
The subjects will receive single oral dose of film coated tablets rifampicin 600 mg on Day 1 of treatment period 3 under fasted condition.
Other Name: Eremfat




Primary Outcome Measures :
  1. Geometric mean ratio of maximum observed plasma peak concentration (Cmax) for verinurad [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with (cyclosporine or rifampicin), relative to reference treatment (verinurad+allopurinol alone) in each treatment period

  2. Geometric mean ratio of area under plasma concentration-time curve from time zero to infinity (AUCinf) for verinurad [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Verinurad AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  3. Geometric mean ratio of area under the plasma concentration-time curve from zero to time of last quantifiable concentration (AUClast) for verinurad [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Verinurad AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period


Secondary Outcome Measures :
  1. Geometric mean ratio of Cmax for verinurad metabolite: M1 [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  2. Geometric mean ratio of Cmax for verinurad metabolite: M8 [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  3. Geometric mean ratio of AUCinf for verinurad metabolite: M1 [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  4. Geometric mean ratio of AUCinf for verinurad metabolite: M8 [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  5. Geometric mean ratio of AUClast for verinurad metabolite: M1 [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  6. Geometric mean ratio of AUClast for verinurad metabolite: M8 [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  7. Geometric mean ratio of Cmax for allopurinol [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Allopurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  8. Geometric mean ratio of AUCinf for allopurinol [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Allopurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  9. Geometric mean ratio of AUClast for allopurinol [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Allopurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  10. Geometric mean ratio of Cmax for oxypurinol [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Oxypurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  11. Geometric mean ratio of AUCinf for oxypurinol [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Oxypurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  12. Geometric mean ratio of AUClast for oxypurinol [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Oxypurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period

  13. Cmax [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Cmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  14. AUCinf [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUCinf of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  15. AUClast [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUClast of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  16. Area under the concentration-time curve from time zero to 24 hours post-dose [AUC(0-24)] [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    AUC(0-24) of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  17. Time to reach peak or maximum observed concentration following drug (tmax) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    tmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  18. Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    t½λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  19. Terminal elimination rate constant (λz) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  20. Apparent total body clearance of drug from plasma after extravascular administration (CL/F) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    CL/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  21. Mean Residence Time of the unchanged drug in the systemic circulation (MRTinf) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    MRTinf of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  22. Volume of distribution (apparent) at steady state following extravascular administration (Vss/F) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Vss/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  23. Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    Vz/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  24. Metabolite:Parent (MP) ratio of Cmax [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    MP ratio of Cmax for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  25. MP ratio of AUCinf [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    MP ratio of AUCinf for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  26. MP ratio of AUClast [ Time Frame: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-dose ]
    MP ratio of AUClast for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period

  27. Number of subjects with abnormal blood pressure (BP) [ Time Frame: For approximately 9 weeks (from screening to follow-up) ]
    Observed values and change from baseline value in systolic and diastolic BP for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  28. Number of subjects with abnormal pulse rate [ Time Frame: For approximately 9 weeks (from screening to follow-up) ]
    Observed values and change from baseline value in pulse rate for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  29. Number of subjects with abnormal temperature [ Time Frame: For approximately 9 weeks (from screening to follow-up) ]
    Observed values and change from baseline value in temperature for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  30. Number of subjects with abnormal 12-lead electrocardiogram (ECG) [ Time Frame: At screening and post-treatment follow-up visit (7-14 day after last dose of verinurad) ]
    12-lead resting ECG safety assessments if there are any abnormal findings for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  31. Number of subjects with abnormal physical examination [ Time Frame: For approximately 9 weeks (from screening to follow-up) ]
    Any new or aggravated clinically relevant abnormal medical physical examination finding compared to the baseline assessment for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  32. Number of subjects with abnormal hematology parameters [ Time Frame: At screening, Day -1, Day 3 (Treatment Periods 1, 2 and 3) and post-treatment follow-up (7-14 days after last dose of verinurad) ]
    Observed values and change from baseline value in hematology parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  33. Number of subjects with abnormal clinical chemistry parameters [ Time Frame: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad) ]
    Observed values and change from baseline value in clinical chemistry parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  34. Number of subjects with abnormal urinalysis parameters [ Time Frame: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad) ]
    Observed values and change from baseline value in urinalysis parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin

  35. Number of subjects with adverse events (AEs) and serious AEs [ Time Frame: For approximately 9 weeks (from screening to follow-up) ]
    The number and percentage of subjects with AEs and the number of events for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin



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:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent form prior to any study specific procedures.
  • Healthy male or female subjects aged 18 - 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
  • Females must be either (1) Of non-childbearing potential, confirmed at Screening by fulfilling one of the following criteria (i) Post-menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH) levels in the post-menopausal range (FSH >40 IU/mL).

(ii) Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.

  • Male subjects must adhere to the contraception methods.
  • Have a body mass index between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).
  • Must be able to swallow multiple capsules/tablets.

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
  • Subject has a positive test result for severe acute respiratory syndrome coronavirus 2 before dosing in Treatment Period 1.
  • Has clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19) infection, eg fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
  • History of severe COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
  • History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of verinurad.
  • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at Screening (Visit 1) and on first admission (Day -1 in Treatment Period 1) as judged by the Investigator, including:

Alanine aminotransferase >1.5 × Upper limit of normal (ULN) Aspartate aminotransferase >1.5 × ULN Bilirubin (total) >1.5 × ULN Gamma glutamyl transpeptidase >1.5 × ULN If any of these tests are out of range, the test can be repeated once at the Screening Visit at the discretion of the Investigator.

  • Any clinically significant abnormal findings in vital signs at Screening Visit and/or on admission (Day -1 in Treatment Period 1) to the Clinical Unit, including, but not limited to, any of the following:

    1. Systolic blood pressure <90 mmHg or >140 mmHg and/or diastolic blood pressure <50 mmHg or >90 mmHg sustained for more than 10 minutes while resting in a supine position
    2. Heart rate (resting, supine) <50 or >90 bpm
  • Any clinically significant abnormalities on 12-lead electrocardiogram at Screening Visit, as judged by the Investigator, including, but not limited to any of the following:

    1. QTcF > 450 ms or < 340 ms or family history of long QT syndrome,
    2. Any significant arrhythmia,
    3. Conduction abnormalities,
    4. Clinically significant PR(PQ) interval prolongation (> 240 ms); intermittent second or third degree atrioventricular (AV) block, or AV dissociation,
    5. Complete bundle branch block and/or QRS duration > 120 ms.
  • Any positive result at Screening Visit for serum hepatitis B surface antigen or anti-hepatitis B core antibody, hepatitis C antibody, and human immunodeficiency virus antibody.
  • Suspicion or known Gilbert's and/or Lesch-Nyhan syndrome
  • History of hypersensitivity to drugs with a similar chemical structure or class to verinurad, allopurinol, cyclosporine or rifampicin or excipients.
  • Subjects who wear soft contact lenses (due to possible staining from rifampicin), unless the subject is prepared to refrain from wearing soft lenses throughout Treatment Period 3 until after the last PK sample collection.
  • Women of childbearing potential.
  • Carrier of the Human leukocyte antigen B*58:01 allele.
  • Has received another new chemical or biological entity (defined as a compound which has not been approved for marketing in the US or EU) within 30 days or within 5 half-lives (whichever is longer) of the first administration of verinurad in this study.
  • Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to Novel uric acid transporter 1 transporter inhibitor & xanthine oxidase inhibitor.
  • Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
  • Positive screen for drugs of abuse, cotinine or alcohol at Screening or on each admission to the Clinical Unit.
  • Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of verinurad.
  • Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
  • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women.
  • Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the Investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day or would likely be unable to refrain from the use of caffeine-containing beverages during in-house stay at the investigational site.
  • Involvement of any AstraZeneca, Parexel or Clinical Unit employee or their close relatives.
  • Judgment by the Investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
  • Subjects who are vegans or have medical dietary restrictions.
  • Subjects who cannot communicate reliably with the Investigator and/or are not able to read, speak and understand the German language.
  • Vulnerable subjects, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

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): NCT04532918


Locations
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Germany
Research Site
Berlin, Germany, 14050
Sponsors and Collaborators
AstraZeneca
Parexel
Investigators
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Principal Investigator: Thomas Kӧrnicke, MD Parexel Early Phase Clinical Unit Berlin
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04532918    
Other Study ID Numbers: D5495C00013
First Posted: August 31, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Pharmacokinetics
Cyclosporine
Rifampicin
Drug-Drug interaction
Organic anion transporting polypeptide (OATP1B) 1
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Cyclosporine
Rifampin
Allopurinol
Verinurad
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antimetabolites
Gout Suppressants
Free Radical Scavengers
Antioxidants
Protective Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers