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

First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080

Phase 1

Completed

Conditions: Clinical Trials, Phase I as Topic

Interventions: Drug: BAY1817080
Drug: Placebo
Drug: Itraconazole

First Posted Date: 2016-06-29

Last Posted Date: 2017-09-06

Lead Sponsor: Bayer

Target Recruit Count: 88

Registration Number: NCT02817100

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

Study to Assess Pharmacokinetic Drug-Drug Interaction Between Avatrombopag When Co-Administered With Fluconazole, Itraconazole, or Rifampin in Healthy Subjects

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Avatrombopag
Drug: Fluconazole
Drug: Itraconazole
Drug: Rifampin

First Posted Date: 2016-06-22

Last Posted Date: 2017-03-09

Lead Sponsor: Eisai Inc.

Target Recruit Count: 48

Registration Number: NCT02809768

A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects

Phase 1

Completed

Conditions: Thrombosis

Interventions: Drug: BMS-986177
Drug: Itraconazole
Drug: Diltiazem ER

First Posted Date: 2016-06-21

Last Posted Date: 2016-09-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 28

Registration Number: NCT02807909

A Study to Determine the Effects of Itraconazole on the Pharmacokinetics (PK) of DS-8500 in Healthy Subjects

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: DS-8500a
Drug: Itraconazole

First Posted Date: 2016-06-06

Last Posted Date: 2019-02-12

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 26

Registration Number: NCT02790671

Locations: 🇺🇸
Worldwide Clinical Trials, San Antonio, Texas, United States

A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma

Phase 1

Completed

Conditions: Glioblastoma

Interventions: Drug: Temozolomide
Drug: Aprepitant
Drug: Minocycline
Drug: Disulfiram
Drug: Celecoxib
Drug: Sertraline
Drug: Captopril
Drug: Itraconazole
Drug: Ritonavir
Drug: Auranofin

First Posted Date: 2016-05-12

Last Posted Date: 2021-10-05

Lead Sponsor: University of Ulm

Target Recruit Count: 10

Registration Number: NCT02770378

Locations: 🇩🇪
University of Ulm School of Medicine, Ulm, Baden-Württemberg, Germany

Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients

Early Phase 1

Conditions: Esophageal Cancer

Interventions: Drug: Itraconazole

First Posted Date: 2016-04-25

Last Posted Date: 2021-11-04

Lead Sponsor: Dallas VA Medical Center

Target Recruit Count: 18

Registration Number: NCT02749513

Locations: 🇺🇸
Dallas VA Medical Center, Dallas, Texas, United States

Topical Itraconazole in Treating Patients With Basal Cell Cancer

Early Phase 1

Completed

Conditions: Skin Basal Cell Carcinoma

Interventions: Drug: Itraconazole
Other: Placebo

First Posted Date: 2016-04-12

Last Posted Date: 2019-04-11

Lead Sponsor: Jean Yuh Tang

Target Recruit Count: 9

Registration Number: NCT02735356

Locations: 🇺🇸
Stanford Cancer Institute, Palo Alto, California, United States

A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: JNJ-53718678
Drug: Itraconazole
Drug: Rifampicin

First Posted Date: 2016-04-06

Last Posted Date: 2016-08-18

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 33

Registration Number: NCT02729467

Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer

Early Phase 1

Withdrawn

Conditions: Skin Basal Cell Carcinoma

Interventions: Drug: Arsenic Trioxide
Drug: Itraconazole
Other: Laboratory Biomarker Analysis

First Posted Date: 2016-03-04

Last Posted Date: 2020-10-22

Lead Sponsor: Jean Yuh Tang

Registration Number: NCT02699723

Effect of Itraconazole on the Pharmacokinetics of BIIB074

Phase 1

Completed

Conditions: Neuropathic Pain

Interventions: Drug: BIIB074
Drug: Itraconazole

First Posted Date: 2016-03-03

Last Posted Date: 2016-06-09

Lead Sponsor: Biogen

Target Recruit Count: 16

Registration Number: NCT02698267

Locations: 🇬🇧
Research Site, Leeds, United Kingdom

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