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Clinical trials for Pharmacokinetics

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    5,858 result(s) found for: Pharmacokinetics. Displaying page 54 of 293.
    EudraCT Number: 2020-001350-21 Sponsor Protocol Number: APL2-PNH-209 Start Date*: 2020-12-08
    Sponsor Name:Apellis Pharmaceuticals, Inc.
    Full Title: An Open-Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients with Paroxysmal Nocturnal Hemoglobinuria
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003787-48 Sponsor Protocol Number: BP41674 Start Date*: 2020-06-11
    Sponsor Name:F. Hoffmann-La Roche
    Full Title: AN OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO7248824 IN PARTICIPANTS WITH ANGELMAN SYNDROME
    Medical condition: Angelman Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10049004 Angelman's syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003230-93 Sponsor Protocol Number: CCFZ533X2202 Start Date*: 2018-05-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, placebo-controlled, patient and investigator blinded study investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple doses of CFZ533 in patients wi...
    Medical condition: Lupus Nephritis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10025140 Lupus nephritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-001010-15 Sponsor Protocol Number: REVC003 Start Date*: 2019-10-24
    Sponsor Name:ReViral Ltd.
    Full Title: A Phase 2a Open-Label Study in Infants with REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability,...
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000676-11 Sponsor Protocol Number: URO-901-3007 Start Date*: 2022-12-30
    Sponsor Name:Urovant Sciences GmbH
    Full Title: A Phase 2/3, Open-label, Baseline-controlled, Multicenter, Long-term Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age with...
    Medical condition: Neurogenic Detrusor Overactivity (NDO)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10029279 Neurogenic bladder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Trial now transitioned) SK (Trial now transitioned) NO (Prematurely Ended) LV (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) PL (Ongoing) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003756-16 Sponsor Protocol Number: BP43445 Start Date*: 2022-03-18
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE MASKED, ACTIVE COMPARATORCONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINIST...
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) CZ (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000134-30 Sponsor Protocol Number: I5B-MC-JGDJ Start Date*: 2015-09-22
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin plus Olaratumab versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma
    Medical condition: Advanced or Metastatic Soft Tissue Sarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10041298 Soft tissue sarcomas histology unspecified HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) HU (Completed) DE (Completed) ES (Ongoing) AT (Completed) FR (Completed) SE (Ongoing) FI (Completed) BE (Completed) NL (Ongoing) PL (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002375-34 Sponsor Protocol Number: EFC15299 Start Date*: 2020-07-23
    Sponsor Name:Genzyme Corporation
    Full Title: A multicenter, multinational, randomized, double-blind, placebo-controlled study to assess the efficacy, pharmacodynamics, pharmacokinetics, safety, and tolerability of venglustat in late-onset GM2...
    Medical condition: Tay-Sachs disease Sandhoff disease
    Disease: Version SOC Term Classification Code Term Level
    23.0 10010331 - Congenital, familial and genetic disorders 10043147 Tay-Sachs disease LLT
    23.0 10010331 - Congenital, familial and genetic disorders 10081314 Sandhoff disease LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (GB - no longer in EU/EEA) PT (Prematurely Ended) AT (Completed) FR (Completed) ES (Completed) CZ (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002694-11 Sponsor Protocol Number: D5160C00007 Start Date*: 2014-12-17
    Sponsor Name:AstraZeneca AB
    Full Title: A phase III, double-blind, randomised study to assess the efficacy and safety of AZD9291 versus a standard of care Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as first-line treatment...
    Medical condition: Locally advanced or metastatic non-small cell lung cancer, not amenable to curative surgery or radiotherapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (GB - no longer in EU/EEA) IT (Completed) DE (Completed) ES (Completed) BE (Completed) SE (Completed) CZ (Completed) FR (Completed) PL (Completed) BG (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2013-001790-25 Sponsor Protocol Number: FP01C-13-001 Start Date*: 2014-09-01
    Sponsor Name:Foresee Pharmaceuticals Co., Ltd.
    Full Title: An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects with Advanced Prostate Carcinoma
    Medical condition: Advanced Prostate Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10036921 Prostate carcinoma LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Completed) DE (Completed) CZ (Completed) SK (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-001318-40 Sponsor Protocol Number: SN38-SPL9111-001 Start Date*: 2019-08-07
    Sponsor Name:Starpharma Pty Ltd
    Full Title: A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SN38-SPL9111 (DEP®-SN38), a SN38 dendrimer conjugate, in patients with advanced ...
    Medical condition: Advanced solid tumours.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007050 Cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-004521-17 Sponsor Protocol Number: BIT-001 Start Date*: 2018-02-19
    Sponsor Name:BIT Pharma GmbH
    Full Title: A Phase IIa: single ascending dose safety, tolerability and pharmacokinetic study of NicaPlant® in aneurysmal subarachnoid haemorrhage patients undergoing aneurysm clipping
    Medical condition: Aneurysmal subarachnoid haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10008111 Cerebral haemorrhage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002763-26 Sponsor Protocol Number: 814-PM-02 Start Date*: 2019-01-17
    Sponsor Name:NeRRe Therapeutics Ltd,
    Full Title: A DOUBLE-BLIND, RANDOMISED, PLACEBO CONTROLLED, ADAPTIVE DESIGN STUDY OF THE EFFICACY, SAFETY AND PHARMACOKINETICS OF NT-814 IN FEMALE SUBJECTS WITH MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED...
    Medical condition: Hot flushes (vasomotor symptoms) in menopausal women
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10027311 Menopause flushing LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-005238-37 Sponsor Protocol Number: 1184.10 Start Date*: 2005-07-06
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A single dose, placebo-controlled, randomized, double-blind, double-dummy, crossover efficacy, pharmacokinetics and safety comparison of salmeterol inhalation powder (25 µg salmeterol), administere...
    Medical condition: All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a pre-dose...
    Disease: Version SOC Term Classification Code Term Level
    8.0 10010952 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-021413-23 Sponsor Protocol Number: 07-0036 Start Date*: 2010-09-28
    Sponsor Name:University of Athens, Medical School
    Full Title: Optimizing Dosing of Colistin for Infections Resistant to all Other Antibiotics
    Medical condition: Bloodstream infection (bacteremia) or hospital-acquired pneumonia by Gram-negative bacillus lacking susceptibility to all of the following antibiotics: cefepime OR ceftazidime, imipenem OR meropene...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10060562 Bacteremia, unspecified LLT
    12.1 10064977 Acinetobacter bacteremia LLT
    12.1 10054228 Gram-negative bacteremia LLT
    12.1 10054279 Escherichia coli bacteremia LLT
    12.1 10054281 Escherichia bacteremia LLT
    12.1 10058883 Klebsiella bacteremia LLT
    12.1 10058884 Enterobacter bacteremia LLT
    12.1 10058925 Serratia bacteremia LLT
    12.1 10058926 Hemophilus bacteremia LLT
    12.1 10058927 Pseudomonal bacteremia LLT
    12.1 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001157-97 Sponsor Protocol Number: D9614C00099 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca AB
    Full Title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Multiple Doses of Esomeprazole Magnesium in a Pediatric Population of 1 to 11 Year olds with Gastroesophageal Reflux Disease (GERD...
    Medical condition: The target subject population was male and female children, aged 1 to 11 years inclusive, who suffered from GERD or symptoms of GERD and were candidates for acid suppression therapy.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017885 Gastrooesophageal reflux disease PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005800-27 Sponsor Protocol Number: 204957 Start Date*: 2016-11-08
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with ...
    Medical condition: Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001189-40 Sponsor Protocol Number: 3 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Tartu
    Full Title: PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE
    Medical condition: cardiac failure, ascites and/or oedema
    Disease: Version SOC Term Classification Code Term Level
    17.0 10007541 - Cardiac disorders 10010394 Congenital cardiac disorders HLGT
    17.0 10018065 - General disorders and administration site conditions 10049630 Oedema due to renal disease PT
    17.0 10018065 - General disorders and administration site conditions 10030103 Oedema generalized LLT
    17.0 10017947 - Gastrointestinal disorders 10003445 Ascites PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003731-22 Sponsor Protocol Number: MK-0431A-296 Start Date*: 2020-09-03
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study to Assess the Pharmacokinetics and Ability for Pediatric Patients with Type 2 Diabetes to Swallow MK-0431A XR Tablets
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2004-004529-84 Sponsor Protocol Number: BM18106 Start Date*: 2005-04-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: Multicenter, double-blind, randomized, placebo controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPP-IV inhibitor RO0730699 in patient...
    Medical condition: Type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    7 10012613 low
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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