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Clinical trials for CYP3A

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   44339   clinical trials with a EudraCT protocol, of which   7369   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 ).  
     
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    24 result(s) found for: CYP3A. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2007-004844-59 Sponsor Protocol Number: CAEB071A2117 Start Date*: 2008-01-31
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A two part, randomized, placebo controlled study to evaluate the pharmacokinetics and cardiovascular pharmacodynamics of AEB071 in combination with ritonavir in healthy volunteers
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003269-46 Sponsor Protocol Number: PedMicMida Start Date*: 2015-04-02
    Sponsor Name:Erasmus MC - Sophia
    Full Title: Pediatric microdosing midazolam: elucidating age-related changes in oral drug absorption
    Medical condition: Age-related changes in drug absorption and metabolism in children
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001550-98 Sponsor Protocol Number: C-GBM(XRP6258) Start Date*: 2013-10-04
    Sponsor Name:University Hospital of Ulm
    Full Title: Prospective controlled phase 2 trial of cabazitaxel in patients with temozolomide refractory glioblastoma multiforme (GBM) - The C-GBM Study -
    Medical condition: •Patients with diagnosis glioblastoma multiforme (GBM) WHO grade IV ; •Progression during or within 6 months after last temozolomide treatment; •Time since last temozolomide > 21 days
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000690-36 Sponsor Protocol Number: TED14856 Start Date*: 2018-12-17
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, then in Combination with Palbociclib in Postmenopausal...
    Medical condition: Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) PT (Prematurely Ended) ES (Prematurely Ended) CZ (Completed) PL (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001440-18 Sponsor Protocol Number: IACI2016 Start Date*: 2018-05-30
    Sponsor Name:university medical center utrecht
    Full Title: Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls
    Medical condition: cystic fibrosis and healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-001046-13 Sponsor Protocol Number: BUC-58/BIO Start Date*: 2006-04-19
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Pharmacokinetic interaction study between budesonide and metronidazole in healthy volunteers
    Medical condition: Healthy male volunteers
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001525-10 Sponsor Protocol Number: bins1 Start Date*: 2013-07-30
    Sponsor Name:Erasmus MC
    Full Title: Studying the metabolism of sorafenib (Nexavar®) by OATP1B blockage in adult cancer patients
    Medical condition: Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001759-38 Sponsor Protocol Number: K675 Start Date*: 2019-12-04
    Sponsor Name:Ruprecht-Karls University Heidelberg Medical Faculty, University Hospital represented in law by its commercial director
    Full Title: Pharmacokinetics of a microdosed cocktail containing rivaroxaban, apixaban and edoxaban in children with congenital heart defects
    Medical condition: 20 children with non-cyanotic congenital heart defects especially atrial septal defects (ASD) and ventricular septal defects (VSD) in admitted to the paediatric cardiology wards will be included. T...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-007948-34 Sponsor Protocol Number: ANRS 144 Start Date*: 2009-02-27
    Sponsor Name:Agence nationale de recherches sur le sida et les hépatites virales. ANRS.
    Full Title: Essai randomisé en double insu comparant l’efficacité et la tolérance du tartrate de varénicline versus placebo dans l’aide à l’arrêt de la consommation de tabac chez les patients infectes infectés...
    Medical condition: Sevrage tabagique chez les patients VIH+ "tobacco user"
    Disease: Version SOC Term Classification Code Term Level
    11.1 10057581 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004453-71 Sponsor Protocol Number: AMLSG31-19 Start Date*: 2022-02-01
    Sponsor Name:University Hospital Ulm
    Full Title: A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrom...
    Medical condition: AML or MDS-EB2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000447-27 Sponsor Protocol Number: USKH_VL1 Start Date*: 2012-07-25
    Sponsor Name:Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Full Title: Open Label Study for the Functional Characterization of Drug Metabolism and Transport in patients before routine visceral surgery
    Medical condition: Pharmacokinetic trial in patients, with a good general condition before standard abdominal surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2015-005275-24 Sponsor Protocol Number: TACPKPD Start Date*: 2016-03-18
    Sponsor Name:HOSPITAL UNIVERSITARI DE BELLVITGE
    Full Title: Conversion pharmacodynamic study in stable renal transplant patients receiving tacrolimus two times a day to a new formulation of tacrolimus - LCP Tacro - 1 time a day.
    Medical condition: REJECTION PROPHYLAXIS IN RENAL TRANSPLANT PATIENTS
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10050436 Prophylaxis against renal transplant rejection LLT
    18.1 10042613 - Surgical and medical procedures 10038533 Renal transplant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003651-54 Sponsor Protocol Number: 2014RISP1 Start Date*: 2015-10-14
    Sponsor Name:UMCG
    Full Title: ‘Off-label use of Risperidone in Children and Adolescents (ORCA): a double-blind placebo-controlled discontinuation trial’
    Medical condition: no specific condition, we will investigate children who have been using risperidone on an off-label basis for at least one year.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002550-39 Sponsor Protocol Number: PDY13949 Start Date*: 2016-10-20
    Sponsor Name:Genzyme Corporation
    Full Title: 4-part, open-label, multicenter, multinational study of the safety, tolerability, pharmacokinetics, pharmacodynamic, and exploratory efficacy of venglustat in combination with Cerezyme in adult pat...
    Medical condition: Gaucher disease
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10075699 Gaucher's disease type III PT
    24.1 10010331 - Congenital, familial and genetic disorders 10075697 Gaucher's disease type I PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000301-87 Sponsor Protocol Number: RP-3500-01 Start Date*: 2020-12-22
    Sponsor Name:Repare Therapeutics
    Full Title: Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination with Talazoparib in Advanced Solid Tumors with ATR inhibitor ...
    Medical condition: Advanced/recurrent solid tumors which have ATRi sensitizing biomarkers,
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004171-39 Sponsor Protocol Number: INCB39110-214 Start Date*: 2020-01-10
    Sponsor Name:Incyte Corporation
    Full Title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
    Medical condition: Bronchiolitis Obliterans Syndrome following Lung Transplantation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10049202 Bronchiolitis obliterans LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10029888 Obliterative bronchiolitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-005402-10 Sponsor Protocol Number: EFC17215 Start Date*: 2022-03-23
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A phase 3, multicenter, multinational, randomized, double-blind, double-dummy, active-comparator study to evaluate the efficacy and safety of venglustat in adult and pediatric patients with Gaucher...
    Medical condition: Gaucher's disease type III
    Disease: Version SOC Term Classification Code Term Level
    24.1 10010331 - Congenital, familial and genetic disorders 10075699 Gaucher's disease type III PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) HU (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-023856-97 Sponsor Protocol Number: 205MS302 Start Date*: 2011-09-22
    Sponsor Name:Biogen Idec Limited
    Full Title: A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneo...
    Medical condition: Relapsing-remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-004455-36 Sponsor Protocol Number: NP28673 Start Date*: 2013-04-11
    Sponsor Name:F.Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER PHASE I/II TRIAL OF RO5424802 GIVEN ORALLY TO NON - SMALL CELL LUNG CANCER PATIENTS WHO HAVE ALK MUTATION AND FAILED CRIZOTINIB TREATMENT
    Medical condition: ALK-mutated Non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) IT (Completed) ES (Completed) NL (Completed) BE (Completed) FR (Completed) DK (Completed) LU (Completed)
    Trial results: View results
    EudraCT Number: 2019-002449-39 Sponsor Protocol Number: 42756493BLC2003 Start Date*: 2020-07-10
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Inva...
    Medical condition: Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusions Cohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) GB (GB - no longer in EU/EEA) ES (Temporarily Halted) PL (Trial now transitioned) BE (Completed) FR (Trial now transitioned) CZ (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
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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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