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

Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects

Phase 1

Completed

Conditions: Non-smokers
Healthy Volunteers

Interventions: Drug: Pracinostat
Drug: Itraconazole
Drug: Ciprofloxacin

First Posted Date: 2014-04-21

Last Posted Date: 2017-02-23

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 32

Registration Number: NCT02118909

Locations: 🇺🇸
Celerion, Tempe, Arizona, United States

Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: CE/BZA
Drug: Itraconazole

First Posted Date: 2014-04-01

Last Posted Date: 2015-03-25

Lead Sponsor: Pfizer

Target Recruit Count: 24

Registration Number: NCT02100553

Locations: 🇺🇸
SeaView Research, Inc. (Screening Office), Miami, Florida, United States
🇺🇸
SeaView Research, Inc., Miami, Florida, United States

To Assess the Effect of Itraconazole and Fluconazole on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers

Phase 1

Completed

Conditions: Solid Tumours

Interventions: Drug: selumetinib
Drug: itraconazole
Drug: fluconazole

First Posted Date: 2014-03-21

Last Posted Date: 2015-06-30

Lead Sponsor: AstraZeneca

Target Recruit Count: 26

Registration Number: NCT02093728

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of JNJ-42165279 in Healthy Male Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: JNJ-42165279
Drug: Itraconazole

First Posted Date: 2014-02-19

Last Posted Date: 2014-04-23

Lead Sponsor: Janssen Pharmaceutica N.V., Belgium

Target Recruit Count: 16

Registration Number: NCT02065739

A 3-Part, Open-Label, Drug-Drug Interaction Study of Concomitant Administration of E2609 With Itraconazole, Rifampin, Digoxin, or Donepezil

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: E2609
Drug: itraconazole
Drug: rifampin
Drug: digoxin
Drug: donepezil

First Posted Date: 2014-02-05

Last Posted Date: 2015-11-03

Lead Sponsor: Eisai Inc.

Target Recruit Count: 195

Registration Number: NCT02055703

Locations: 🇺🇸
WCT Early Development, San Antonio, Texas, United States

Phase Ib/II Study Evaluating Orteronel (Without Prednisone) Combined With Itraconazole In Men With Castration-Resistant Prostate Cancer (CRPC)

Phase 1

Withdrawn

Conditions: Castration-resistant Prostate Cancer
Prostate Cancer

First Posted Date: 2014-02-04

Last Posted Date: 2014-07-23

Lead Sponsor: Emmanuel Antonarakis, MD

Registration Number: NCT02054793

Locations: 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Sibley Memorial Hospital, Washington, District of Columbia, United States

Interaction of BI 691751 With Itraconazole

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 691751
Drug: itraconazole

First Posted Date: 2014-01-24

Last Posted Date: 2015-12-16

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 20

Registration Number: NCT02044393

Locations: 🇩🇪
1334.10.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Single and Multiple Dose Study of Uprifosbuvir (MK-3682/IDX21437) in Healthy and Hepatitis C Virus (HCV)-Infected Participants (MK-3682-001)

Phase 1

Completed

Conditions: Chronic Hepatitis C

Interventions: Drug: Uprifosbuvir
Drug: Itraconazole
Drug: Placebo

First Posted Date: 2013-11-01

Last Posted Date: 2018-09-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 178

Registration Number: NCT01974687

A Study of the Effect of Multiple Doses of Itraconazole and Fluoxetine on the Pharmacokinetics of a Single Dose of RO5285119 in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: RO5285119
Drug: itraconazole
Drug: fluoxetine

First Posted Date: 2013-10-23

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 28

Registration Number: NCT01967979

A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Cobimetinib
Drug: Itraconazole

First Posted Date: 2013-08-28

Last Posted Date: 2016-08-04

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 16

Registration Number: NCT01929876

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