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    DRUG:

    itraconazole

    Company:
    Generic mfg.
    Drug class:
    CYP51A1 inhibitor
    Related drugs:
    3d
    A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants (clinicaltrials.gov)
    P1, N=18, Recruiting, Genentech, Inc. | Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Jul 2025 | Trial primary completion date: Jan 2025 --> Jul 2025
    Enrollment open • Trial completion date • Trial primary completion date
    |
    divarasib (RG6330) • itraconazole
    9d
    A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov)
    P1, N=56, Completed, Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting --> Completed
    Trial completion
    |
    itraconazole • VC004 • rifampicin
    10d
    529 DDI ITZ: A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=12, Recruiting, AbbVie
    New P1 trial
    |
    itraconazole
    13d
    A Study of the Effect of Itraconazole and Phenytoin on MK-1084 in Healthy Adults (MK-1084-008) (clinicaltrials.gov)
    P1, N=28, Completed, Merck Sharp & Dohme LLC
    New P1 trial
    |
    MK-1084 • itraconazole
    17d
    Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=32, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P1 trial • Metastases
    |
    trastuzumab rezetecan (SHR-A1811) • itraconazole • ritonavir
    22d
    BGB-11417-107: A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers (clinicaltrials.gov)
    P1, N=30, Completed, BeiGene | Recruiting --> Completed
    Trial completion
    |
    itraconazole • sonrotoclax (BGB-11417)
    22d
    A Study to Learn if the Study Medicine Called Itraconazole Changes How the Body Processes the Other Study Medicine Called PF-07258669 In Older Adults (clinicaltrials.gov)
    P1, N=14, Not yet recruiting, Pfizer
    New P1 trial
    |
    itraconazole
    23d
    Clinical and Physiologically Based Pharmacokinetic Model Evaluations of Adagrasib Drug-Drug Interactions. (PubMed, Clin Pharmacol Ther)
    The PBPK model well-described the single and multiple-dose adagrasib PK data as well as DDI data with itraconazole, rifampin, midazolam, warfarin, dextromethorphan, and digoxin, with model predictions within 1.5-fold of the observed clinical data. is predicted to be a strong inhibitor of CYP3A4, a moderate inhibitor of CYP2C9 and CYP2D6, and an inhibitor of P-glycoprotein (P-gp). These results successfully supported regulatory interactions with the United States Food and Drug Administration regarding dosing recommendations for when adagrasib is used concomitantly with other medications, supporting a range of label claims in lieu of clinical trials.
    PK/PD data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CYP2C9 (Cytochrome P450 Family 2 Subfamily C Member 9) • CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Krazati (adagrasib) • itraconazole • midazolam hydrochloride • rifampicin
    26d
    A Double-Blind, Placebo-Controlled, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZE50 0134 in Healthy Volunteers (ACTRN12624000093583)
    P1, N=88, Recruiting, Eilean Therapeutics AU Pty Ltd (A subsidiary of Eilean Therapeutics LLC) | N=40 --> 88
    Enrollment change • Trial initiation date
    |
    itraconazole
    27d
    WX081-DDI: Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Shanghai Jiatan Pharmatech Co., Ltd
    New P1 trial
    |
    itraconazole • rifampicin
    28d
    Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2). (clinicaltrials.gov)
    P2, N=15, Terminated, AstraZeneca | N=100 --> 15 | Trial completion date: Dec 2025 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Jul 2024; Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    itraconazole
    28d
    A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=112, Recruiting, AbbVie
    New P1 trial
    |
    itraconazole
    28d
    A Phase II Trial to Evaluate the Effect of Itraconazole on Pathologic Complete Response Rates in Resectable Esophageal Cancer (clinicaltrials.gov)
    P2, N=78, Recruiting, VA Office of Research and Development | Not yet recruiting --> Recruiting
    Enrollment open
    |
    itraconazole
    1m
    A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Genentech, Inc.
    New P1 trial
    |
    divarasib (RG6330) • itraconazole
    1m
    Evaluation of drug-drug interactions of a novel potent FLT3 inhibitor SKLB1028 in healthy subjects. (PubMed, Clin Transl Sci)
    Based on the preclinical characterization of SKLB1028 metabolism, three drug-drug interaction clinical studies were performed to investigate the effects of itraconazole, rifampin (CYP3A4 inhibitor and inducer, respectively), and gemfibrozil (CYP2C8 inhibitor) on the metabolism of SKLB1028. Co-administration with rifampin reduced the AUC of SKLB1028 by ~30%, while the Cmax did not change significantly. All treatments were well tolerated in all three studies.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    itraconazole • rifampicin • ruserontinib (SKLB-1028)
    1m
    A Study of the Effects of Itraconazole on the Plasma Levels of Nemtabrutinib (MK-1026-013) (clinicaltrials.gov)
    P1, N=15, Completed, Merck Sharp & Dohme LLC
    New P1 trial
    |
    itraconazole • nemtabrutinib (MK-1026)
    1m
    A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov)
    P1, N=22, Recruiting, Immunome, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    itraconazole • varegacestat (AL102)
    1m
    MK-1708-008: A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003) (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    itraconazole
    1m
    A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants (clinicaltrials.gov)
    P1, N=12, Completed, PMV Pharmaceuticals, Inc | Recruiting --> Completed
    Trial completion
    |
    itraconazole • rezatapopt (PC14586)
    1m
    A Single-center, Open-label, Fixed-sequence, Drug-Drug Interaction Study of BPI-16350 co-administered with Rifampin or Itraconazole in Healthy Volunteers (ChiCTR2400090190)
    P1, N=36, Completed, Beijing Friendship Hospital ,Capital Medical University; Beijing Friendship Hospital ,Capital Medical University
    New P1 trial
    |
    itraconazole • tibremciclib (BPI-16350) • rifampicin
    1m
    A Phase 1 Study to Examine the Effects of Itraconazole After Single Dose Administration of Varegacestat (AL102) to Healthy Participants (clinicaltrials.gov)
    P1, N=22, Not yet recruiting, Immunome, Inc.
    New P1 trial
    |
    itraconazole • varegacestat (AL102)
    1m
    A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China (clinicaltrials.gov)
    P1, N=16, Completed, Nanjing Zenshine Pharmaceuticals | Not yet recruiting --> Completed
    Trial completion
    |
    itraconazole
    1m
    A Study to Investigate the Pharmacokinetics of AZD0780 When Administered Alone and in Combination With Itraconazole and Carbamazepine in Healthy Participants Aged 18 to 75 Years of Age (clinicaltrials.gov)
    P1, N=42, Recruiting, AstraZeneca
    New P1 trial • Combination therapy
    |
    itraconazole
    1m
    A Phase 1 Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of Multiple Doses of ALG-000184. (clinicaltrials.gov)
    P1, N=24, Not yet recruiting, Aligos Therapeutics
    New P1 trial
    |
    itraconazole
    2ms
    A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor (clinicaltrials.gov)
    P1, N=34, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Aug 2025 --> Feb 2025
    Trial completion date • Metastases
    |
    TP53 (Tumor protein P53)
    |
    TP53 wild-type
    |
    brigimadlin (BI 907828) • itraconazole • rifampicin
    2ms
    Drug-Drug Interaction (DDI) Study for TQB3616 (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial
    |
    culmerciclib (TQB3616) • itraconazole • rifampicin
    2ms
    Study to Evaluate the Drug-drug Interaction of JMKX003142 in Healthy Subjects (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Jemincare
    New P1 trial
    |
    itraconazole • rifampicin
    2ms
    MK-1708-008: A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003) (clinicaltrials.gov)
    P1, N=12, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    itraconazole
    2ms
    A PK Study of IkT-148009 in Older and Elderly Healthy Subjects (clinicaltrials.gov)
    P1, N=8, Completed, Inhibikase Therapeutics, Inc.
    New P1 trial
    |
    itraconazole
    2ms
    Itraconazole to Prevent Recurrent Barrett's Esophagus (clinicaltrials.gov)
    P1, N=10, Active, not recruiting, University of Kansas Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Feb 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    itraconazole
    2ms
    A Study to Assess the Pharmacokinetics of AZD6793 When Administered Alone and in Combination With Itraconazole in Healthy Participants. (clinicaltrials.gov)
    P1, N=17, Completed, AstraZeneca | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    itraconazole
    2ms
    A Study to Learn if the Study Medicines Called Itraconazole and Cyclosporine Change How the Body Processes the Other Study Medicine Called Danuglipron in Healthy Adults. (clinicaltrials.gov)
    P1, N=16, Not yet recruiting, Pfizer | Trial completion date: Oct 2024 --> Mar 2025 | Initiation date: Aug 2024 --> Dec 2024 | Trial primary completion date: Oct 2024 --> Mar 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    itraconazole • cyclosporine
    2ms
    A Study to Evaluate the Effects of D-1553 on PK of Midazolam, Caffeine, Rosuvastatin, Furosemide, Digoxin, and Itraconazole or Omeprazole on PK of D-1553 (clinicaltrials.gov)
    P1, N=45, Completed, InventisBio Co., Ltd | Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Feb 2024
    Trial completion • Trial completion date
    |
    garsorasib (D-1553) • itraconazole • midazolam hydrochloride • omeprazole
    3ms
    Early prediction and impact assessment of CYP3A4-related drug-drug interactions for small molecule anti-cancer drugs using human-CYP3A4-transgenic mouse models. (PubMed, Drug Metab Dispos)
    Victim drugs brigatinib and lorlatinib were evaluated with the new approach in combination with the perpetrator drugs itraconazole and rifampicin. The model was able to adequately describe the inhibition of CYP3A4 metabolism and the subsequent magnitude of change in exposure. However, it was unable to accurately predict the magnitude of change in exposure of victim drugs in combination with an inducer.
    Preclinical • Journal
    |
    CYP3A4 (Cytochrome P450, family 3, subfamily A, polypeptide 4)
    |
    Lorbrena (lorlatinib) • Alunbrig (brigatinib) • itraconazole • rifampicin
    3ms
    A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov)
    P1, N=56, Not yet recruiting, Jiangsu vcare pharmaceutical technology co., LTD
    New P1 trial
    |
    itraconazole • VC004 • rifampicin
    3ms
    A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants (clinicaltrials.gov)
    P1, N=35, Completed, Celgene | Recruiting --> Completed
    Trial completion
    |
    itraconazole • golcadomide (CC-99282) • rifampicin
    3ms
    A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients (clinicaltrials.gov)
    P1, N=60, Terminated, University of Chicago | N=100 --> 60 | Trial completion date: Apr 2025 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> Aug 2024; Terminated by the PI
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    itraconazole • Orgovyx (relugolix) • ritonavir
    3ms
    A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088 (clinicaltrials.gov)
    P1, N=66, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open
    |
    itraconazole
    3ms
    A Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558 (clinicaltrials.gov)
    P1, N=144, Active, not recruiting, Aligos Therapeutics | Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Nov 2024
    Enrollment closed • Trial completion date
    |
    itraconazole • midazolam hydrochloride
    3ms
    A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants (clinicaltrials.gov)
    P1, N=50, Active, not recruiting, DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Recruiting --> Active, not recruiting | Trial completion date: Jun 2024 --> Dec 2024
    Enrollment closed • Trial completion date
    |
    itraconazole
    3ms
    To compare the efficacy and safety of low-dose venetoclax combined with azole and full-dose venetoclax without azole in the treatment of newly diagnosed AML patients who are intolerant to intensive chemotherapy (ChiCTR2400087406)
    P=N/A, N=60, Not yet recruiting, The First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital); Department of Hematology of Anhui Provinci
    New trial
    |
    Venclexta (venetoclax) • itraconazole • Noxafil (posaconazole)
    3ms
    A Study to Evaluate the Effect of Itraconazole on the Concentration of GSK3923868 in the Blood in Healthy Participants (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, GlaxoSmithKline
    New P1 trial
    |
    itraconazole