Itraconazole

Generic Name: Itraconazole

Brand Names: Sporanox, Tolsura

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₃₈Cl_₂N_₈O_₄

CAS Number: 84625-61-6

Unique Ingredient Identifier: 304NUG5GF4

Background: One of the triazole antifungal agents that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ergosterol synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.

Indication: For the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: pulmonary and extrapulmonary blastomycosis, histoplasmosis, aspergillosis, and onychomycosis.

Associated Conditions: Aspergillosis, Blastomycosis, Chromoblastomycosis, Coccidioidal meningitis, Esophageal Candidiasis, Fungal Infections, Fungal skin infection, Histoplasmosis, Onychomycosis, Oropharyngeal Candidiasis, Paracoccidioidomycosis, Penicillium marneffei infection, Pulmonary coccidioides, Sporotrichosis, Vulvovaginal Candidiasis, Disseminated Other specified protozoal diseases

Associated Therapies: -

Clinical Trials

Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction

Phase 1

Completed

Conditions: Biological Availability

Interventions: Drug: BAY1841788 (ODM-201)
Drug: Itraconazole
Drug: Rifampicin

First Posted Date: 2017-02-09

Last Posted Date: 2018-07-30

Lead Sponsor: Bayer

Target Recruit Count: 15

Registration Number: NCT03048110

Locations: 🇩🇪
CRS Clinical Research Services Berlin GmbH, Berlin, Germany

A Study of LY3323795 in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: LY3323795
Drug: Itraconazole

First Posted Date: 2016-12-12

Last Posted Date: 2020-04-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 42

Registration Number: NCT02989389

Locations: 🇺🇸
California Clinical Trials Medical Group, Glendale, California, United States

Evaluation of Metabolic Markers for the Prediction of DDI of Various CYP3A Substrates and Inhibitors

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Sildenafil
Drug: Clarithromycin
Drug: Itraconazole

First Posted Date: 2016-11-29

Last Posted Date: 2022-10-27

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 32

Registration Number: NCT02975037

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

Phase 4

Terminated

Conditions: Hematologic Neoplasms

Interventions: Drug: Caspofungin
Drug: Itraconazole

First Posted Date: 2016-09-09

Last Posted Date: 2019-05-06

Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.

Target Recruit Count: 61

Registration Number: NCT02895529

An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults.

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: PF-06648671
Drug: Itraconazole

First Posted Date: 2016-08-30

Last Posted Date: 2016-12-20

Lead Sponsor: Pfizer

Target Recruit Count: 12

Registration Number: NCT02883114

Locations: 🇺🇸
Pfizer New Haven Clinical Research Unit, New Haven, Connecticut, United States

A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

Phase 1

Terminated

Conditions: Neoplasms
Lymphoma, Non-Hodgkin

Interventions: Drug: CC-90011
Drug: Rifampicin
Drug: Itraconazole

First Posted Date: 2016-08-23

Last Posted Date: 2024-04-19

Lead Sponsor: Celgene

Target Recruit Count: 75

Registration Number: NCT02875223

Locations: 🇮🇹
Local Institution - 201, Milano, Italy
🇯🇵
Local Institution - 500, Kashiwa, Japan
🇯🇵
Local Institution - 501, Chuo-ku, Tokyo, Japan

and more 12 locations

A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: PF-06463922
Drug: Itraconazole

First Posted Date: 2016-07-20

Last Posted Date: 2017-05-15

Lead Sponsor: Pfizer

Target Recruit Count: 16

Registration Number: NCT02838264

Locations: 🇧🇪
Pfizer Clinical Research Unit, Brussels, Belgium

Drug-Drug Interaction Study of AG120 in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: AG120
Drug: Itraconazole

First Posted Date: 2016-07-13

Last Posted Date: 2017-06-27

Lead Sponsor: Agios Pharmaceuticals, Inc.

Target Recruit Count: 22

Registration Number: NCT02831972

Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole

Phase 1

Completed

Conditions: Medical Oncology

Interventions: Drug: Anetumab ravtansine (BAY94-9343)
Drug: Itraconazole

First Posted Date: 2016-07-06

Last Posted Date: 2020-07-31

Lead Sponsor: Bayer

Target Recruit Count: 63

Registration Number: NCT02824042

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇦🇺
Blacktown Cancer & Haematology Centre, Blacktown, New South Wales, Australia
🇫🇷
Centre Georges Francois Leclerc Dijon, Dijon, France

and more 15 locations

Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: CC-220
Drug: Itraconazole
Drug: Rifampin

First Posted Date: 2016-07-01

Last Posted Date: 2016-10-18

Lead Sponsor: Celgene Corporation

Target Recruit Count: 36

Registration Number: NCT02820935

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

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