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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
13d
New P1 trial
|
MK-1084 • itraconazole
17d
New P1 trial • Metastases
|
trastuzumab rezetecan (SHR-A1811) • itraconazole • ritonavir
22d
Trial completion
|
itraconazole • sonrotoclax (BGB-11417)
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
Enrollment change • Trial initiation date
|
itraconazole
27d
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
Enrollment open
|
itraconazole
1m
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
New P1 trial
|
itraconazole • nemtabrutinib (MK-1026)
1m
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
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
New P1 trial
|
itraconazole • varegacestat (AL102)
1m
Trial completion
|
itraconazole
1m
New P1 trial
|
itraconazole
2ms
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
New P1 trial
|
itraconazole • rifampicin
2ms
Enrollment open
|
itraconazole
2ms
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
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
New P1 trial
|
itraconazole • VC004 • rifampicin
3ms
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
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)